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Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)

Primary Purpose

Prostate Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

177Lu-PSMA-617

Best supportive/best standard of care

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Metastatic castration-resistant prostate cancer, mCRPC, 177Lu-PSMA-617, PSMA-617, PSMA-11, radioligand therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have the ability to understand and sign an approved informed consent form (ICF).
Patients must have the ability to understand and comply with all protocol requirements.
Patients must be >= 18 years of age.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Patients must have a life expectancy >6 months.
Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader.
Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).
Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if: a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.).
Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
2. Soft-tissue progression defined as an increase >= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.
3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria, Scher et al 2016).
Patients must have >= 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained =< 28 days prior to beginning study therapy.
Patients must have recovered to =< Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
Patients must have adequate organ function:
a. Bone marrow reserve:
- White blood cell (WBC) count >= 2.5 x 10^9/L (2.5 x 10^9/L is equivalent to 2.5 x 10^3/μL and 2.5 x K/μL and 2.5 x 10^3/cumm and 2500/μL) OR absolute neutrophil count (ANC) >= 1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/μL and 1.5 x K/μL and 1.5 x 10^3/cumm and 1500/μL)
- Platelets >= 100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/μL and 100 x K/μL and 100 x 10^3/cumm and 100,000/μL)
- Hemoglobin >= 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L) b. Hepatic:
- Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =< 3 x ULN is permitted
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 3.0 x ULN OR =< 5.0 x ULN for patients with liver metastases c. Renal:
- Serum/plasma creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min
Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) [Inclusion #16 has been removed]

17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial.

18. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.

19. The best standard of care/ best supportive care options planned for this patient:

Are allowed by the protocol
Have been agreed to by the treating investigator and patient
Allow for the management of the patient without 177Lu-PSMA-617

Exclusion Criteria:

Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of randomization.
Any investigational agents within 28 days prior to day of randomization.
Known hypersensitivity to the components of the study therapy or its analogs.
Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
Transfusion for the sole purpose of making a subject eligible for study inclusion.
Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
A superscan as seen in the baseline bone scan.
Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.

Sites / Locations

HonorHealth Research Institute
University of Arizona Cancer Center
VA Greater Los Angeles Healthcare System
University of California Los Angeles, Nuclear Medicine
Stanford Cancer Institute
UCSF Helen Diller Family Comprehensive Cancer Center
University of Colorado Hospital
Yale Cancer Center
Washington DC VA Medical Center, Nuclear Medicine Service
H. Lee Moffitt Cancer Center & Research Institute
Northwestern University
Parkview Research Center
Indiana University Melvin and Bren Simon Cancer Center
University of Iowa Hospitals and Clinics
Iowa City VA Medical Center
Norton Cancer Institute
Tulane Medical Center, Tulane Cancer Center
University of Maryland Greenebaum Cancer Center
Chesapeake Urology Associates (CUA) P.A.
Dana Farber Cancer Institute
Beth Israel Deaconess Medical Center
VA Ann Arbor Healthcare System
University of Michigan Hospitals
Karmanos Cancer Center
Mayo Clinic - Rochester
Saint Louis University Hospital
VA St. Louis Health Care System - John Cochran
Washington University School of Medicine
XCancer Omaha / Urology Cancer Center
Comprehensive Cancer Centers of Nevada - Twain Office
Regional Cancer Care Associates, Central Jersey Division
New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center
Memorial Sloan Kettering Cancer Center
New York Presbyterian Hospital/Weill Cornell Medical Center
Duke University Medical Center, Duke Cancer Center
Greater Dayton Cancer Center
Oregon Health and Science University, Nuclear Medicine
Pennsylvania Cancer Specialists & Research Institute
Thomas Jefferson University Hospital
Carolina Urologic Research Center
VA North Texas Health Care System, Nuclear Medicine Service
UT Southwestern Medical Center
Excel Diagnostics & Nuclear Oncology Center
Emily Couric Clinical Cancer Center
Swedish Cancer Institute Research
Jules Bordet Institute
Saint Luc University Hospital
University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine
BC Cancer - Vancouver
London Health Sciences Centre, Division of Nuclear Medicine
Ottawa Hospital, Cancer Center
Sunnybrook Research Institute, Odette Cancer Center
CHUM - University Hospital of Montreal
Jewish General Hospital
CHU of Quebec - Laval University
Aalborg University Hospital, Oncology Department
Aarhus University Hospital, Department of Oncology
Rigshospitalet - University Hospital Copenhagen, Department of Oncology
Bergonie Institute
Center Jean Perrin
Leon Berard Center
Saint-Louis Hospital
Tenon Hospital
Institute Claudius Regaud, Toulouse Cancer Research Center
Gustave Roussy Oncology Institute
University Hospital Essen, Clinic for Nuclear Medicine
University Hospital Muenster, Department of Nuclear Medicine
Hospital rechts der Isar, Department of Nuclear Medicine
Rostock University Medical Center, Clinic and Polyclinic for Nuclear Medicine
The Netherlands Cancer Institute
St. Antonius Hospital
Radboud University Medical Center (Radboudumc)
UMC Utrecht
VA Caribbean Healthcare System
Sahlgrenska University Hospital, Department of Oncology
Skane University Hospital - Barngatan, Clinical Trials Unit
Karolinska University Hospital
Norrlands University Hospital, Cancer Center
Uppsala University Hospital, Department of Oncology
Bristol Hematology & Oncology Center
Beatson West of Scotland Cancer Center
Royal Surrey County Hospital
Guy's Hospital
Royal Free Hospital
St Bartholomew's Hospital
University College London Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Institute of Cancer Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)

Best supportive/best standard of care (BS/BSOC) alone

Arm Description

Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used

Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator

Outcomes

Primary Outcome Measures

Radiographic Progression-free Survival (rPFS)

Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of randomization to the date of radiographic disease progression based on the central review assessment per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause. Patients who were alive without radiographic progression at the analysis data cut-off were censored for rPFS at the time of their last evaluable radiographic assessment. Date of censoring for rPFS: 1) The censoring date was the date when the last evaluable radiographic assessment (CT/MRI/bone scan) determined a lack of progression; 2) If there were no evaluable assessments, censoring occurred at the date of randomization; 3) Patients who had 2 or more consecutive missed tumor assessments immediately prior to PD or death were censored at the date of the last evaluable tumor assessment prior to those missing tumor assessments.

Overall Survival (OS)

Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date.

Secondary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events

The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters.

Overall Response Rate (ORR)

Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline per central review assessment.

Disease Control Rate (DCR)

Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 per central review assessment.

Duration of Response (DOR)

Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as per central review assessment.

Time to First Symptomatic Skeletal Event (SSE)

Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of randomization to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. SSE data for this endpoint were collected up through EOT visit. The censoring date was date of the last study visit (on or before the EOT visit).

Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the time (in months) from the date of randomization to the date of first evidence of radiographic, clinical or PSA progression or death due to any cause, whichever occurred first.

Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level

Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).

Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response

PSA response was defined as the proportion of patients who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.

Prostate-specific Antigen 80 (PSA80) Response

PSA80 response was defined as the proportion of participants who had a >= 80% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.

Duration of PSA Response

Duration of PSA response was defined as the duration between the date of first document PSA response (i.e. >= 50% decrease in PSA from Baseline) and the earliest date of PSA progression, where date of PSA progression was defined as: 1) Where a decline from baseline was documented, date that a >= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose of randomized treatment were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a >= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose of randomized treatment (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines.

Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level

Best percentage change from baseline in alkaline phosphatase (ALP) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).

Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level

Best percentage change from baseline in lactate dehydrogenase (LDH) level was defined as the maximum percent decrease at any time post-baseline, including only patients with a baseline value and at least one non-missing post-baseline value (scheduled and unscheduled).

Time to Worsening in BPI-SF Pain Intensity Scale

Time to worsening in BPI-SF pain intensity scale was defined as the time from randomization to the first occurring of an increase of worsening threshold (>=30% of baseline or >=2-point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death.

Time to Improvement After Worsening in BPI-SF Pain Intensity Scale

Time to improvement after worsening in BPI-SF pain intensity scale was defined as the time from worsening of Pain Intensity score to a Pain Intensity score <= baseline.

Time to Worsening in BPI-SF Pain Interference Scale

Time to worsening in BPI-SF pain interference scale was defined as the time from randomization to the first occurring of 1) an increase of worsening threshold (>=30% of baseline or >=2-point increase) at any time up through EOT visit compared to baseline, 2) clinical disease progression, or 3) death.

Time to Improvement After Worsening in BPI-SF Pain Interference Scale

Time to improvement after worsening in BPI-SF pain interference scale was defined as the time from worsening of Pain Interference score to a Pain Interference score <= baseline.

Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain)

Time to worsening in BPI-SF worst pain intensity scale (time to disease related pain) was defined as the time from randomization to the first occurring of worsening exceeding the threshold threshold (>=30% of baseline or >=2 point increase) at any time up through EOT visit compared to baseline, clinical disease progression, or death.

Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Intensity Scale

The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Intensity items consist of an 11-response rating scale scored from 0 ("No Pain") to 10 ("Pain As Bad As You Can Imagine"). BPI-SF Pain intensity is the mean of non-missing items of the 4 individual scales, if there are 3 or more items not missing; otherwise this scale is set to missing.

Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale

The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Interference items consist of scores from 0 ("Does Not Interfere") to 10 ("Completely Interferes"). BPI-SF Interference scale is the mean of non-missing items of the 7 items on pain interference, if there are 4 or more items not missing; otherwise this scale is set to missing.

Time to Worsening in FACT-P Total Score

Time to worsening was defined as the time from randomization to the first occurring of a >=10 point decrease in FACT-P total score compared to baseline, clinical disease progression, or death.

Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score

The FACT-P total score (range 0-156) consist of five subscales (Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24)) and a functional well-being and prostate cancer subscale (range 0-48). Higher scores indicate higher degree of functioning and better quality of life.

Time to Worsening in EQ-5D-5L Utility Score

Time to worsening for utility score was defined as time from randomization to the first occurrence of worsening in utility score relative to baseline (no change or any decrease), clinical disease progression, or death.

Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score

The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales. The weights were based on value sets which were country-specific for the U.K. Utility scores ranges from the lowest possible score for a living patient of -0.594 (when all responses are '5') to 1 (when all responses are '1').If a patient died, he was assigned a score of 0 on the date of death.

Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS

The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The higher the EQ-VAS score, the better the QoL.

Number of Participants Hospitalized as In-patient

The number of hospitalizations (yes/no) (admitted as in-patient) was collected as part of the hospital admission for health economic evaluations.

Duration of Time in Hospital Following 177Lu-PSMA-617 Administration

The duration of time in hospital following 177Lu-PSMA-617 administration (hours) was the time span of patient discharged as captured on the 177Lu-PSMA-617 administration Case Report Form (CRF).

Concomitant Drug Use for Health Economics Analysis

The list of concomitant drugs as captured on the concomitant medication/therapy CRF page to include in each category was pre-specified and flagged prior to the pre planned analyses. (1) Bisphosphonates (including but not limited to zoledronic acid, alendronic acid, etc.), denosumab, and other bone targeted therapies), (2) Corticosteroids for systemic use (3), Antifungals for systemic use (i.e. ketoconazole), (4) ESA (erythropoietin stimulating agents, i.e. epoetin alfa), (5) Granulocyte macrophage colony-stimulating factor (GM-CSF), (6) Novel androgen axis drugs (NAADs; i.e. enzalutamide, abiraterone, apalutamide), (7) Antiemetics and (8) Opioid analgesics use for cancer-related pain.

Therapeutic Interventions for Health Economics Analysis

The list of therapeutic interventions was pre-specified and flagged prior to the pre planned analyses as captured on: 1) the concurrent radiotherapy CRF page to include local external beam radiotherapy (inclusive of palliative external radiation), 2) on the concomitant medication/therapy CRF page to include blood transfusion (full blood or derivates).

Full Information

NCT ID

NCT03511664

First Posted

April 13, 2018

Last Updated

October 4, 2023

Sponsor

Endocyte

1. Study Identification

Unique Protocol Identification Number

NCT03511664

Brief Title

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

Acronym

VISION

Official Title

VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 29, 2018 (Actual)

Primary Completion Date

January 27, 2021 (Actual)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endocyte

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.

Detailed Description

The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period. Screening and randomization: During the screening period of up to 28 days before starting randomized treatment, each participant was assessed for PSMA positivity by gallium (68Ga) gozetotide imaging PET/scan per the pre-defined read rules, by the Sponsor's central reader. Only patients with PSMA-positive metastatic PC and meeting all other inclusion/exclusion criteria were randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus BSC/BSoC or BSC/BSoC only. Randomized patients were stratified on the following factors: LDH level (=< or > 260 UI/L), presence of liver metastases (Yes or No), eastern cooperative oncology group (ECOG) score (0-1 or 2) and inclusion of NAAD in the BSC/BSoC (at time of randomization (Yes or No)). Protocol- specified BSC/BSoC for each patient was initiated by the investigating physician prior to patient randomization and maintained throughout the study. On-study changes to BSC/BSoC were allowed and at the discretion of the investigating physician. Randomized treatment: "Randomized treatment" in this study referred to 177Lu-PSMA- 617+BSC/BSoC (investigational arm) and BSC/BSoC only (control arm). Patients randomized to the investigational arm began 177Lu-PSMA-617 administration within 28 days after randomization (C1D1). These patients received 7.4 gigabecquerel (GBq) (+/- 10%) 177Lu-PSMA-617 once every 6 weeks (+/- 1 week) for a maximum of 6 cycles while receiving BSC/BSoC. After Cycle 4 treatment and prior to Cycle 5 treatment, the investigator assessed the following criteria to determine whether: The patient showed evidence of response (i.e., radiological, PSA, clinical benefit). The patient had signs of residual disease on CT with contrast/MRI or bone scan. The patient had shown good tolerance to the 177Lu-PSMA-617 treatment. If the patient met all the criteria above and agreed to continue with additional treatment of 177Lu-PSMA-617, the Investigator could administer 2 additional cycles. A maximum of 6 cycles of 177Lu-PSMA-617 as allowed. If the patient did not meet any of the criteria or did not agree to additional 177Lu-PSMA-617 treatment, then no additional doses of 177Lu-PSMA- 617 were administered after Cycle 4. After the last cycle of 177Lu-PSMA- 617, patients continued to be treated with BSC/BSoC as long as the investigator felt they were clinically benefiting (regardless of radiographic progressive disease based on Investigator's assessment per PCWG3 criteria) or until they required a treatment regimen not allowed on this study. For both treatment arms, the cycle duration for Cycle 1-6 was 6 weeks and for Cycle 7 and beyond, was 12 weeks. From Cycle 7 onwards, all patients from both treatment arms only received BSC/BSoC. End of treatment: The EOT visit was scheduled approximately 30 days after the last dose of 177Lu-PSMA-617 or the date of the BSC/BSoC EOT decision (whichever occurred later), but before the initiation of subsequent anti-cancer treatment, outside of what was allowed on study. Long-term follow-up: Patients who consented to be followed for long-term status updates, entered the long-term follow-up period after the EOT visit. The long-term follow-up included the collection of radiographic images (if a patient discontinued for reasons other than radiographic progression), OS, information about new treatments along with the patient's response to these treatments, AE assessment, and results of hematology and chemistry testing. During the follow-up, patients are contacted every 3 months (+/-1 month) via phone, email, or letter until the end of long-term the follow-up period (24 months after the first patient enters long-term follow-up) or until 508 deaths had occurred.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Metastatic castration-resistant prostate cancer, mCRPC, 177Lu-PSMA-617, PSMA-617, PSMA-11, radioligand therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

The study population included patients with progressive PSMA-positive mCRPC who received at least one novel androgen axis drug [NAAD] (such as enzalutamide or abiraterone) and were previously treated with 1 to 2 taxane containing regimens. Patients treated with only 1 prior taxane regimen were eligible if the patient was unwilling or the patient's physician deemed the patient unsuitable to receive a second regimen.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

831 (Actual)

8. Arms, Groups, and Interventions

Arm Title

177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)

Arm Type

Experimental

Arm Description

Arm Title

Best supportive/best standard of care (BS/BSOC) alone

Arm Type

Other

Arm Description

Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator

Intervention Type

Drug

Intervention Name(s)

177Lu-PSMA-617

Intervention Description

Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. After 4 cycles, patients were assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments were met the patient might received an additional 2 cycles of 177Lu-PSMA-617.

Intervention Type

Other

Intervention Name(s)

Best supportive/best standard of care

Intervention Description

Best supportive/best standard of care as defined by the local investigator

Primary Outcome Measure Information:

Title

Radiographic Progression-free Survival (rPFS)

Description

Time Frame

From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Overall Survival (OS)

Description

Time Frame

From date of randomization until date of death from any cause, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment Emergent Adverse Events

Description

Time Frame

From randomization till 30 days safety follow-up, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Overall Response Rate (ORR)

Description

Time Frame

From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Disease Control Rate (DCR)

Description

Time Frame

From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Duration of Response (DOR)

Description

Time Frame

From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Time to First Symptomatic Skeletal Event (SSE)

Description

Time Frame

From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Progression-free Survival (PFS)

Description

Time Frame

From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level

Description

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response

Description

PSA response was defined as the proportion of patients who had a >= 50% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Prostate-specific Antigen 80 (PSA80) Response

Description

PSA80 response was defined as the proportion of participants who had a >= 80% decrease in PSA from baseline confirmed by a PSA measurement >= 4 weeks later.

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Duration of PSA Response

Description

Time Frame

From date of first documented PSA response till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level

Description

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level

Description

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Time to Worsening in BPI-SF Pain Intensity Scale

Description

Time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Time to Improvement After Worsening in BPI-SF Pain Intensity Scale

Description

Time to improvement after worsening in BPI-SF pain intensity scale was defined as the time from worsening of Pain Intensity score to a Pain Intensity score <= baseline.

Time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Time to Worsening in BPI-SF Pain Interference Scale

Description

Time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Time to Improvement After Worsening in BPI-SF Pain Interference Scale

Description

Time to improvement after worsening in BPI-SF pain interference scale was defined as the time from worsening of Pain Interference score to a Pain Interference score <= baseline.

Time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain)

Description

Time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Intensity Scale

Description

Time Frame

Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)

Title

Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale

Description

The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Interference items consist of scores from 0 ("Does Not Interfere") to 10 ("Completely Interferes"). BPI-SF Interference scale is the mean of non-missing items of the 7 items on pain interference, if there are 4 or more items not missing; otherwise this scale is set to missing.

Time Frame

Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)

Title

Time to Worsening in FACT-P Total Score

Description

Time to worsening was defined as the time from randomization to the first occurring of a >=10 point decrease in FACT-P total score compared to baseline, clinical disease progression, or death.

Time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score

Description

Time Frame

Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)

Title

Time to Worsening in EQ-5D-5L Utility Score

Description

Time Frame

From date of randomization until date of End of Treatment (EoT), assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score

Description

Time Frame

Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)

Title

Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS

Description

The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue 0-100 scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The higher the EQ-VAS score, the better the QoL.

Time Frame

Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)

Title

Number of Participants Hospitalized as In-patient

Description

The number of hospitalizations (yes/no) (admitted as in-patient) was collected as part of the hospital admission for health economic evaluations.

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Duration of Time in Hospital Following 177Lu-PSMA-617 Administration

Description

The duration of time in hospital following 177Lu-PSMA-617 administration (hours) was the time span of patient discharged as captured on the 177Lu-PSMA-617 administration Case Report Form (CRF).

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Concomitant Drug Use for Health Economics Analysis

Description

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

Title

Therapeutic Interventions for Health Economics Analysis

Description

Time Frame

From date of randomization till 30 days safety fup, assessed up to 43 months (Final OS analysis cut-off date = 27-Jan-2021)

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have the ability to understand and sign an approved informed consent form (ICF). Patients must have the ability to understand and comply with all protocol requirements. Patients must be >= 18 years of age. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Patients must have a life expectancy >6 months. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer. Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader. Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone). Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if: a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.). Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL. Soft-tissue progression defined as an increase >= 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria, Scher et al 2016). Patients must have >= 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained =< 28 days prior to beginning study therapy. Patients must have recovered to =< Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.). Patients must have adequate organ function: a. Bone marrow reserve: White blood cell (WBC) count >= 2.5 x 10^9/L (2.5 x 10^9/L is equivalent to 2.5 x 10^3/μL and 2.5 x K/μL and 2.5 x 10^3/cumm and 2500/μL) OR absolute neutrophil count (ANC) >= 1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/μL and 1.5 x K/μL and 1.5 x 10^3/cumm and 1500/μL) Platelets >= 100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/μL and 100 x K/μL and 100 x 10^3/cumm and 100,000/μL) Hemoglobin >= 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L) b. Hepatic: Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =< 3 x ULN is permitted Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 3.0 x ULN OR =< 5.0 x ULN for patients with liver metastases c. Renal: Serum/plasma creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) [Inclusion #16 has been removed] 17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial. 18. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration. 19. The best standard of care/ best supportive care options planned for this patient: Are allowed by the protocol Have been agreed to by the treating investigator and patient Allow for the management of the patient without 177Lu-PSMA-617 Exclusion Criteria: Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of randomization. Any investigational agents within 28 days prior to day of randomization. Known hypersensitivity to the components of the study therapy or its analogs. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. Transfusion for the sole purpose of making a subject eligible for study inclusion. Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast). A superscan as seen in the baseline bone scan. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

HonorHealth Research Institute

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

University of Arizona Cancer Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719-1454

Country

United States

Facility Name

VA Greater Los Angeles Healthcare System

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

University of California Los Angeles, Nuclear Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Stanford Cancer Institute

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

UCSF Helen Diller Family Comprehensive Cancer Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

University of Colorado Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Yale Cancer Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8028

Country

United States

Facility Name

Washington DC VA Medical Center, Nuclear Medicine Service

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20422

Country

United States

Facility Name

H. Lee Moffitt Cancer Center & Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Parkview Research Center

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

Indiana University Melvin and Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Iowa City VA Medical Center

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52246

Country

United States

Facility Name

Norton Cancer Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Tulane Medical Center, Tulane Cancer Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

University of Maryland Greenebaum Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Chesapeake Urology Associates (CUA) P.A.

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215-5450

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

VA Ann Arbor Healthcare System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Facility Name

University of Michigan Hospitals

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Karmanos Cancer Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Mayo Clinic - Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Saint Louis University Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

VA St. Louis Health Care System - John Cochran

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63106

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110-1093

Country

United States

Facility Name

XCancer Omaha / Urology Cancer Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada - Twain Office

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

Regional Cancer Care Associates, Central Jersey Division

City

East Brunswick

State/Province

New Jersey

ZIP/Postal Code

08816

Country

United States

Facility Name

New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

New York Presbyterian Hospital/Weill Cornell Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Duke University Medical Center, Duke Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Greater Dayton Cancer Center

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Oregon Health and Science University, Nuclear Medicine

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239-3098

Country

United States

Facility Name

Pennsylvania Cancer Specialists & Research Institute

City

Gettysburg

State/Province

Pennsylvania

ZIP/Postal Code

17325

Country

United States

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Carolina Urologic Research Center

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

VA North Texas Health Care System, Nuclear Medicine Service

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Excel Diagnostics & Nuclear Oncology Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77042

Country

United States

Facility Name

Emily Couric Clinical Cancer Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Swedish Cancer Institute Research

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Jules Bordet Institute

City

Brussels

Country

Belgium

Facility Name

Saint Luc University Hospital

City

Brussels

Country

Belgium

Facility Name

University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine

City

Leuven

Country

Belgium

Facility Name

BC Cancer - Vancouver

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

London Health Sciences Centre, Division of Nuclear Medicine

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Ottawa Hospital, Cancer Center

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Sunnybrook Research Institute, Odette Cancer Center

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

CHUM - University Hospital of Montreal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

CHU of Quebec - Laval University

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Aalborg University Hospital, Oncology Department

City

Aalborg

Country

Denmark

Facility Name

Aarhus University Hospital, Department of Oncology

City

Aarhus

Country

Denmark

Facility Name

Rigshospitalet - University Hospital Copenhagen, Department of Oncology

City

Copenhagen

Country

Denmark

Facility Name

Bergonie Institute

City

Bordeaux

Country

France

Facility Name

Center Jean Perrin

City

Clermont-Ferrand

Country

France

Facility Name

Leon Berard Center

City

Lyon

Country

France

Facility Name

Saint-Louis Hospital

City

Paris

Country

France

Facility Name

Tenon Hospital

City

Paris

Country

France

Facility Name

Institute Claudius Regaud, Toulouse Cancer Research Center

City

Toulouse

Country

France

Facility Name

Gustave Roussy Oncology Institute

City

Villejuif

Country

France

Facility Name

University Hospital Essen, Clinic for Nuclear Medicine

City

Essen

Country

Germany

Facility Name

University Hospital Muenster, Department of Nuclear Medicine

City

Muenster

Country

Germany

Facility Name

Hospital rechts der Isar, Department of Nuclear Medicine

City

Munich

Country

Germany

Facility Name

Rostock University Medical Center, Clinic and Polyclinic for Nuclear Medicine

City

Rostock

Country

Germany

Facility Name

The Netherlands Cancer Institute

City

Amsterdam

Country

Netherlands

Facility Name

St. Antonius Hospital

City

Nieuwegein

Country

Netherlands

Facility Name

Radboud University Medical Center (Radboudumc)

City

Nijmegen

Country

Netherlands

Facility Name

UMC Utrecht

City

Utrecht

Country

Netherlands

Facility Name

VA Caribbean Healthcare System

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

Sahlgrenska University Hospital, Department of Oncology

City

Gothenburg

Country

Sweden

Facility Name

Skane University Hospital - Barngatan, Clinical Trials Unit

City

Lund

Country

Sweden

Facility Name

Karolinska University Hospital

City

Stockholm

Country

Sweden

Facility Name

Norrlands University Hospital, Cancer Center

City

Umea

Country

Sweden

Facility Name

Uppsala University Hospital, Department of Oncology

City

Uppsala

Country

Sweden

Facility Name

Bristol Hematology & Oncology Center

City

Bristol

Country

United Kingdom

Facility Name

Beatson West of Scotland Cancer Center

City

Glasgow

Country

United Kingdom

Facility Name

Royal Surrey County Hospital

City

Guildford

Country

United Kingdom

Facility Name

Guy's Hospital

City

London

Country

United Kingdom

Facility Name

Royal Free Hospital

City

London

Country

United Kingdom

Facility Name

St Bartholomew's Hospital

City

London

Country

United Kingdom

Facility Name

University College London Hospitals NHS Foundation Trust

City

London

Country

United Kingdom

Facility Name

University Hospital Southampton NHS Foundation Trust

City

Southampton

Country

United Kingdom

Facility Name

Institute of Cancer Research

City

Sutton

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

31595044

Citation

Iravani A, Violet J, Azad A, Hofman MS. Lutetium-177 prostate-specific membrane antigen (PSMA) theranostics: practical nuances and intricacies. Prostate Cancer Prostatic Dis. 2020 Mar;23(1):38-52. doi: 10.1038/s41391-019-0174-x. Epub 2019 Oct 8.

Results Reference

background

PubMed Identifier

34161051

Citation

Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.

Results Reference

result

PubMed Identifier

33189510

Citation

Sundlov A, Sjogreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12.

Results Reference

derived

Learn more about this trial

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

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