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

Prostate Cancer Clinical Trial

Official title:

A Randomized Phase II Study of 177 LuPSMA-617 vs Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04663997
• Other study ID #: PR21
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 11, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	London Regional Cancer Program	London	Ontario
Canada	CHUM-Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	The Jewish General Hospital	Montreal	Quebec
Canada	Hotel-Dieu de Quebec	Quebec City	Quebec
Canada	CIUSSS de l'Estrie - Centre hospitalier	Sherbrooke	Quebec
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	Endocyte, Prostate Cancer Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		3 years
Secondary	Progression-free survival rate at 6 months defined by PSA		6 months
Secondary	Progression-free survival rate at 6 months defined by PCWG 3		6 months
Secondary	Progression-free survival rate at 6 months defined by RECIST 1.1		6 months
Secondary	Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy		3 years
Secondary	Time to commencement of third line therapy		3 years
Secondary	Overall Survival		3 years
Secondary	Proportions of patients with decreased PSA from baseline and the magnitude of change	e.g. = 30%, = 50%, = 90% decline from baseline	3 years
Secondary	Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1).		3 years
Secondary	Response duration including partial response, complete response or stable disease > 24 (RECIST v1.1)		3 years
Secondary	Adverse event (AE) profile (CTCAE v5.0)		3 years