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68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

Primary Purpose

Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Gallium Ga 68-labeled PSMA-11

Positron Emission Tomography

Questionnaire Administration

About this trial

This is an interventional diagnostic trial for Biochemically Recurrent Prostate Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Patients who fulfill criteria for initial staging or restaging as outlined below:
- Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:
  - Surgery
  - External radiation therapy (RT)
  - Other focal therapies
  - Systemic medical treatment
  - Watchful waiting
- Assessment for subsequent treatment strategy (restaging), any of the following:
  - Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:
    - Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
    - Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
  - Patients with known prostate cancer who undergo restaging because of new symptoms
  - Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
  - Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
  - Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
Capability to provide written informed consent
Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Inability to provide written informed consent

Sites / Locations

UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (68Ga-PSMA-11 PET/CT)

Arm Description

Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

Outcomes

Primary Outcome Measures

Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)

A separate analysis of initial versus subsequent management will be performed. Will be evaluated using descriptive statistics for both the treatment modality analysis and the disease stage based management analysis. Questionnaires will be collected to determine the intended patient management before and intended management changes after PET/CT, and to determine whether intended management changes were implemented. The outcome measure is the rate of change (%) as assessed by the questionnaires before and after PET.

Secondary Outcome Measures

Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS)

Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS

Nodal and visceral disease will be evaluated on cross-sectional imaging using Response Evaluation Criteria in Solid Tumors 1.1/Prostate Cancer Working Group 3 (PCWG3) criteria. Bone metastases will be evaluated using bone scintigraphy and new lesions have to be confirmed on a second scan (2+2 rule) using PCWG3 criteria.

Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival

Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location

Confirmed by histopathology/biopsy or follow-up assessed separately for initial staging and restaging. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. PPV will be reported for each of the three blinded readers independently. Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate-specific antigen (PSA) value will be summarized in tabular format and compared between PSA strata using chi-square analysis. Detection rate is defined as number of patients with PSMA positive disease, independent of pathology, imaging or clinical follow-up. A detection rate will be reported for each reader independently stratified by PSA.

Full Information

NCT ID

NCT04050215

First Posted

August 6, 2019

Last Updated

September 29, 2021

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04050215

Brief Title

68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

Official Title

Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 2, 2018 (Actual)

Primary Completion Date

September 27, 2021 (Actual)

Study Completion Date

September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer. OUTLINE: Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision. After completion of study, patients are followed up within 3-12 months.

6. Conditions and Keywords

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

Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Carcinoma, PSA Level Greater Than Fifty, PSA Progression, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

937 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (68Ga-PSMA-11 PET/CT)

Arm Type

Experimental

Arm Description

Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Intervention Description

Undergo PET/CT

Intervention Type

Drug

Intervention Name(s)

Gallium Ga 68-labeled PSMA-11

Other Intervention Name(s)

(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, Gallium Ga 68 PSMA-11, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Intervention Description

Undergo PET/CT

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)

Description

Time Frame

Up to 3-6 months after completion of imaging

Secondary Outcome Measure Information:

Title

Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS)

Time Frame

From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months

Title

Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS

Description

Time Frame

From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months

Title

Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival

Time Frame

From inclusion to date of death, assessed up to 12 months

Title

Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location

Description

Time Frame

Up to 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who fulfill criteria for initial staging or restaging as outlined below: Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies: Surgery External radiation therapy (RT) Other focal therapies Systemic medical treatment Watchful waiting Assessment for subsequent treatment strategy (restaging), any of the following: Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following: Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA Patients with known prostate cancer who undergo restaging because of new symptoms Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision Capability to provide written informed consent Able to remain still for duration of each imaging procedure (about 30 minutes) Exclusion Criteria: Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance Inability to provide written informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeremie Calais

Organizational Affiliation

UCLA / Jonsson Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA / Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33602654

Citation

Ma TM, Gafita A, Shabsovich D, Juarez J, Grogan TR, Thin P, Armstrong W, Sonni I, Nguyen K, Lok V, Reiter RE, Rettig MB, Steinberg ML, Kupelian PA, Yang DD, Muralidhar V, Chu C, Feng F, Savjani R, Deng J, Parikh NR, Nickols NG, Elashoff D, Czernin J, Calais J, Kishan AU. Identifying the Best Candidates for Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography as the Primary Staging Approach Among Men with High-risk Prostate Cancer and Negative Conventional Imaging. Eur Urol Oncol. 2022 Feb;5(1):100-103. doi: 10.1016/j.euo.2021.01.006. Epub 2021 Feb 16.

Results Reference

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68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

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