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

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ClinicalTrials.gov Identifier: NCT04663997
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : October 18, 2022
Prostate Cancer Canada
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 177Lu-PSMA-617 Drug: Docetaxel Phase 2

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 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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: 177 Lu-PSMA-617 Drug: 177Lu-PSMA-617
IA of 7.4GBq (± 10%) IV every 6 weeks; maximum 6 cycles

Active Comparator: Docetaxel Drug: Docetaxel
75mg/m2 IV every 3 weeks maximum 12 cycles

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Progression-free survival rate at 6 months defined by PSA [ Time Frame: 6 months ]
  2. Progression-free survival rate at 6 months defined by PCWG 3 [ Time Frame: 6 months ]
  3. Progression-free survival rate at 6 months defined by RECIST 1.1 [ Time Frame: 6 months ]
  4. Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy [ Time Frame: 3 years ]
  5. Time to commencement of third line therapy [ Time Frame: 3 years ]
  6. Overall Survival [ Time Frame: 3 years ]
  7. Proportions of patients with decreased PSA from baseline and the magnitude of change [ Time Frame: 3 years ]
    e.g. ≥ 30%, ≥ 50%, ≥ 90% decline from baseline

  8. Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1). [ Time Frame: 3 years ]
  9. Response duration including partial response, complete response or stable disease > 24 (RECIST v1.1) [ Time Frame: 3 years ]
  10. Adverse event (AE) profile (CTCAE v5.0) [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663997

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Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca

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Canada, British Columbia
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kim Chi    604 877-6000 ext 2746      
Canada, Quebec
CHUM-Centre Hospitalier de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Fred Saad    514 890-8000 ext 27466      
The Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Stephan Probst    614 340-8222      
Hotel-Dieu de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Frederic Pouliot    418 525-4444 ext 15598      
CIUSSS de l'Estrie - Centre hospitalier Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Michel Pavic    819 346-1110 ext 74816      
Sponsors and Collaborators
Canadian Cancer Trials Group
Prostate Cancer Canada
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Study Chair: 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
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT04663997    
Other Study ID Numbers: PR21
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Subject to CCTG Policy

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Canadian Cancer Trials Group:
radioligand therapy
metastatic prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action