177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer
NCT ID: NCT04663997
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2021-08-11
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
177Lu-PSMA-617 is a new type of therapy for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. 177Lu-PSMA-617 has been shown to shrink tumours in animals and has been studied in limited numbers of men with prostate cancer and seems promising but it is not clear if it can offer better control of prostate cancer compared to docetaxel chemotherapy .
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
177 Lu-PSMA-617
177Lu-PSMA-617
IA of 7.4GBq (± 10%) IV every 6 weeks; maximum 6 cycles
Docetaxel
Docetaxel
75mg/m2 IV every 3 weeks maximum 12 cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
177Lu-PSMA-617
IA of 7.4GBq (± 10%) IV every 6 weeks; maximum 6 cycles
Docetaxel
75mg/m2 IV every 3 weeks maximum 12 cycles
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prostate Cancer Canada
OTHER
Novartis Pharmaceuticals
INDUSTRY
Canadian Cancer Trials Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kim Chi
Role: STUDY_CHAIR
BCCA - Vancouver Cancer Centre, BC Canada
Francois Benard
Role: STUDY_CHAIR
BCCA - Vancouver Cancer Centre, BC Canada
Fred Saad
Role: STUDY_CHAIR
CHUM-Centre Hospitalier de l'Universite de Montreal, Canada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
London Regional Cancer Program
London, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
The Jewish General Hospital
Montreal, Quebec, Canada
Hotel-Dieu de Quebec
Québec, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR21
Identifier Type: -
Identifier Source: org_study_id