Status:
ACTIVE_NOT_RECRUITING
177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer
Lead Sponsor:
Canadian Cancer Trials Group
Collaborating Sponsors:
Prostate Cancer Canada
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ...
Detailed Description
The standard or usual treatment for this disease is a chemotherapy drug called docetaxel, given by intravenous every 3 weeks, for up to 12 treatments. 177Lu-PSMA-617 is a new type of therapy for pros...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04663997
Start Date
August 11 2021
End Date
December 31 2026
Last Update
November 6 2025
Active Locations (10)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
4
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9