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

Sponsor
Canadian Cancer Trials Group (Other)
Overall Status
Suspended
CT.gov ID
NCT04663997
Collaborator
Prostate Cancer Canada (Other), Endocyte (Industry)
200
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2
55.4
50
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Study Details

Study Description

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
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 .

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 17, 2020
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [3 years]

Secondary Outcome Measures

  1. Progression-free survival rate at 6 months defined by PSA [6 months]

  2. Progression-free survival rate at 6 months defined by PCWG 3 [6 months]

  3. Progression-free survival rate at 6 months defined by RECIST 1.1 [6 months]

  4. Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy [3 years]

  5. Time to commencement of third line therapy [3 years]

  6. Overall Survival [3 years]

  7. Proportions of patients with decreased PSA from baseline and the magnitude of change [3 years]

    e.g. ≥ 30%, ≥ 50%, ≥ 90% decline from baseline

  8. Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1). [3 years]

  9. Response duration including partial response, complete response or stable disease > 24 (RECIST v1.1) [3 years]

  10. Adverse event (AE) profile (CTCAE v5.0) [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
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. radiotherapy to non-target lesions less than 28 day (4 weeks) prior to enrollment. Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG.

  • Presence of majority (> 50% of 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 BCCA - Vancouver Cancer Centre Vancouver British Columbia Canada V5Z 4E6
2 CHUM-Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2X 3E4
3 The Jewish General Hospital Montreal Quebec Canada H3T 1E2
4 Hotel-Dieu de Quebec Quebec City Quebec Canada G1R 2J6

Sponsors and Collaborators

  • Canadian Cancer Trials Group
  • Prostate Cancer Canada
  • Endocyte

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Canadian Cancer Trials Group
ClinicalTrials.gov Identifier:
NCT04663997
Other Study ID Numbers:
  • PR21
First Posted:
Dec 11, 2020
Last Update Posted:
Jun 14, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022