177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer

NCT04663997 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PR21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief Summary

177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body. The purpose of this study is to find out whether 177Lu PSMA 617can slow the growth of prostate cancer compared to standard chemotherapy treatment

Conditions

Prostate Cancer

Keywords

mCRPC; docetaxel; 177Lu-PSMA-617; radioligand therapy; metastatic prostate cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  3 years

Secondary Outcomes (10)

• Progression-free survival rate at 6 months defined by PSA

  6 months

• Progression-free survival rate at 6 months defined by PCWG 3

  6 months

• Progression-free survival rate at 6 months defined by RECIST 1.1

  6 months

• Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy

  3 years

• Time to commencement of third line therapy

  3 years

Study Arms (2)

177 Lu-PSMA-617

EXPERIMENTAL

Drug: 177Lu-PSMA-617

Docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

177Lu-PSMA-617 DRUG

IA of 7.4GBq (± 10%) IV every 6 weeks; maximum 6 cycles

177 Lu-PSMA-617

Docetaxel DRUG

75mg/m2 IV every 3 weeks maximum 12 cycles

Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological evidence of prostate cancer with no evidence of small cell component
• Patients must have castration resistance and metastatic disease with evidence of biochemical or imaging progression in the setting of surgical/medical castration
• Progression on treatment with abiraterone and/or enzalutamide, or similar next-generation androgen receptor (AR) targeted therapy
• Evidence of PSMA positive metastatic disease, as assessed on PSMA-PET imaging studies obtained as part of other clinical trial protocols are mandated, provided they are obtained within a timeframe that meets the requirements of this study. The radiopharmaceuticals must be based on a lysine-urea-glutamate backbone, with a 18F or 68Ga radionuclide label.
• Prior orchiectomy, or if on LHRH agonist/antagonist then testosterone \< 1.7 nmol/L
• Adequate organ function
• Recover from all previous cancer treatment toxicities to grade ≤ 2 (as per CTCAE v5.0)
• Male subject ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

You may not qualify if:

• Prior treatment with chemotherapy for castration-resistant disease or prior chemotherapy in the castration-sensitive (hormone-sensitive) setting ≤ 1 year prior to enrollment.
• Prior treatment with 177Lu-PSMA (including other radiolabeled therapeutic PSMA-ligands) or radio-immunotherapy. Prior treatment with radium-223 is allowed but requires a minimum of a 6-month interval between the last dose of radium-223 and enrollment.
• Radiotherapy to target lesions (measurable disease) ≤ 12 weeks prior to enrolment.
• Presence of majority (\> 50% of extra-osseous lesions) or large (\> 5 cm) soft tissue lesions that are negative on PSMA-Ligand PET/CT or PSMA-Ligand PET/MR
• Known parenchymal brain metastases
• Active epidural disease (treated epidural disease is permitted)
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Clinically significant cardiac disease
• Major surgery within 4 weeks of starting study treatment
• Patients with a history of hypersensitivity to the study drug or components
• Patients with a clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or sever psychiatric illness/social situations.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Prostate Cancer Canada: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (10)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pluvicto; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Kim Chi

  BCCA - Vancouver Cancer Centre, BC Canada

  STUDY CHAIR

• Francois Benard

  BCCA - Vancouver Cancer Centre, BC Canada

  STUDY CHAIR

• Fred Saad

  CHUM-Centre Hospitalier de l'Universite de Montreal, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: August 11, 2021
• Primary Completion: August 25, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)