Back to results

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) (LU-PSMA)

Primary Purpose

Metastatic Castration Resistant Prostate Cancer, 68Ga-PSMA PET/CT Positive

Status

Active

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

177Lu-PSMA

About this trial

This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer focused on measuring Metastatic castration resistant prostate cancer, 68Ga-PSMA PET/CT positive

Eligibility Criteria

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

Inclusion Criteria:

Male, Age > 18 years.
Patients must have histologically or cytologically confirmation of advanced prostate cancer castration resistant defined according to PCWG3 criteria
Measurable disease according to RECIST 1.1. criteria; also patients with bone lesions only could be enrolled
Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT 68Ga-PSMA images demonstrate a significant uptake (tumor to background ratio >2.5) at metastatic tumour site (or in the primary when present, or both)
Patients with documented radiological progression (in soft tissue and / or bone) and / or biochemical progression (sequence of 3 PSA rising values from a screening PSA value ≥ 2 ng / ml) according to PCWG3 in pre-study period, refractory or unfit to conventional standard treatments (hormonal or chemotherapeutic treatment such as abiraterone, enzalutamide and docetaxel)
Concomitant LHRH analogs assumption is allowed
Life expectancy greater than 6 months.
ECOG performance status <2
Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X upper normal limit (UNL), alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <2.5 X UNL (< 5 X UNL in presence of liver metastases, creatinine < 2 mg/dL).
Participant is willing and able to give informed consent for participation in the study
Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma).

Exclusion Criteria:

Patients treated with chemotherapy and 223Ra radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy.
All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE)
ECOG performance status >2
Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Assessed bone marrow invasion > 50%

Sites / Locations

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

177Lu-PSMA

Arm Description

177Lu PSMA

Outcomes

Primary Outcome Measures

Disease Control Rate (DCR )

DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease lasting for at least 6 months from therapy start. DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST).

Incidence of Treatment-Emergent Adverse Events

The evaluation of the Incidence of Treatment-Emergent Adverse Events starts from the 1st treatment until 30 days after the last treatment cycle; Treatment-Emergent Adverse Events are evaluated according to version 4.03 CTC-AE criteria.

Secondary Outcome Measures

Progression free survival (PFS)

PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.

Overall survival (OS)

Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

Full Information

NCT ID

NCT03454750

First Posted

February 27, 2018

Last Updated

May 31, 2023

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

1. Study Identification

Unique Protocol Identification Number

NCT03454750

Brief Title

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC)

Acronym

LU-PSMA

Official Title

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC): Efficacy and Toxicity Evaluation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 25, 2022 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation

Detailed Description

Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation. Single-center, prospective, non controlled, open label, phase II trial. The main objective of this study is to evaluate the Disease Control Rate (DCR) and the safety as co-primary objective. The secondary objectives are: late toxicity, PFS, OS, biochemical response and dosimetry.

6. Conditions and Keywords

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

Metastatic Castration Resistant Prostate Cancer, 68Ga-PSMA PET/CT Positive

Keywords

Metastatic castration resistant prostate cancer, 68Ga-PSMA PET/CT positive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

177Lu-PSMA

Arm Type

Experimental

Arm Description

177Lu PSMA

Intervention Type

Drug

Intervention Name(s)

177Lu-PSMA

Intervention Description

177Lu-PSMA 3.7-5-5 GBq Intravenous Slowly in 15-30 ' Day 1/ every 8-12 weeks Four cycles every 8-12 weeks

Primary Outcome Measure Information:

Title

Disease Control Rate (DCR )

Description

Time Frame

up to 36 months

Title

Incidence of Treatment-Emergent Adverse Events

Description

Time Frame

up to 30 days after the last treatment cycle

Secondary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

Time Frame

up to 36 months

Title

Overall survival (OS)

Description

Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.

Time Frame

up to 36 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male, Age > 18 years. Patients must have histologically or cytologically confirmation of advanced prostate cancer castration resistant defined according to PCWG3 criteria Measurable disease according to RECIST 1.1. criteria; also patients with bone lesions only could be enrolled Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT 68Ga-PSMA images demonstrate a significant uptake (tumor to background ratio >2.5) at metastatic tumour site (or in the primary when present, or both) Patients with documented radiological progression (in soft tissue and / or bone) and / or biochemical progression (sequence of 3 PSA rising values from a screening PSA value ≥ 2 ng / ml) according to PCWG3 in pre-study period, refractory or unfit to conventional standard treatments (hormonal or chemotherapeutic treatment such as abiraterone, enzalutamide and docetaxel) Concomitant LHRH analogs assumption is allowed Life expectancy greater than 6 months. ECOG performance status <2 Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X upper normal limit (UNL), alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <2.5 X UNL (< 5 X UNL in presence of liver metastases, creatinine < 2 mg/dL). Participant is willing and able to give informed consent for participation in the study Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma). Exclusion Criteria: Patients treated with chemotherapy and 223Ra radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy. All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE) ECOG performance status >2 Participation in another clinical trial with any investigational agents within 30 days prior to study screening. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Assessed bone marrow invasion > 50%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanni Paganelli

Organizational Affiliation

IRST IRCCS

Official's Role

Study Chair

Facility Information:

Facility Name

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

City

Meldola

State/Province

ZIP/Postal Code

47014

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

34333554

Citation

De Giorgi U, Sansovini M, Severi S, Nicolini S, Monti M, Gurioli G, Foca F, Casadei C, Conteduca V, Celli M, Di Iorio V, Calistri D, Matteucci F, von Eyben FE, Attard G, Paganelli G. Circulating androgen receptor gene amplification and resistance to 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer: results of a Phase 2 trial. Br J Cancer. 2021 Oct;125(9):1226-1232. doi: 10.1038/s41416-021-01508-5. Epub 2021 Jul 31.

Results Reference

derived

PubMed Identifier

32430583

Citation

Paganelli G, Sarnelli A, Severi S, Sansovini M, Belli ML, Monti M, Foca F, Celli M, Nicolini S, Tardelli E, Marini I, Matteucci F, Giganti M, Di Iorio V, De Giorgi U. Dosimetry and safety of 177Lu PSMA-617 along with polyglutamate parotid gland protector: preliminary results in metastatic castration-resistant prostate cancer patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3008-3017. doi: 10.1007/s00259-020-04856-1. Epub 2020 May 20.

Results Reference

derived

Learn more about this trial

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC)

We'll reach out to this number within 24 hrs