Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apalutamide 60mg Tab — DRUG
  4 tablets by mouth once a day for 24 weeks
• Abiraterone Acetate 250mg — DRUG
  4 tablets by mouth on an empty stomach once a day for 16 weeks
• Prednisone 5mg Tab — DRUG
  1 tablet by mouth once daily while taking abiraterone acetate
• Docetaxel — DRUG
  Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks)
• Niraparib 100mg Oral Capsule — DRUG
  3 capsules by mouth once daily for 16 weeks
• Atezolizumab — DRUG
  1200mg infusion every 3 weeks for 6 cycles
• Tazemetostat Pill — DRUG
  200 mg 4 tablets by mouth twice daily with or without food for 16 weeks
• Capivasertib — DRUG
  200 mg 2 tablets by mouth twice a day with or without food on an intermittent dosing schedule (days 1-4, then 3 days off) each week for 16 weeks

Study Details

The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response. Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks. Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib. The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.

Key Dates

First listed

Mar 23, 2021

Start date

Sep 21, 2021

Status verified

Jul 2026

Primary completion

Jun 1, 2027

Completion

Jun 1, 2027

Study Design

Enrollment

315 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group 1a
  LHRHa plus apalutamide.
• Active Comparator: Group 1b
  LHRHa plus apalutamide plus abiraterone acetate plus prednisone.
• Active Comparator: Group 2a
  LHRHa plus abiraterone acetate plus prednisone.
• Active Comparator: Group 2b
  LHRHa plus abiraterone acetate plus prednisone plus docetaxel.
• Active Comparator: Group 3
  LHRHa plus abiraterone acetate plus prednisone plus niraparib
• Active Comparator: Group 4
  LHRHa plus apalutamide plus atezolizumab
• Active Comparator: Group 5
  LHRHa plus abiraterone acetate plus prednisone plus tazemetostat
• Active Comparator: Group 6
  LHRHa plus abiraterone acetate plus prednisone plus Capivasertib

Primary Outcome Measure

Complete Pathologic Response (pCR) [ Time Frame: 6 years ]

Central Contacts

• Martin E Gleave, MD
  604-875-5006
  [email protected]
• Doron Berlin
  [email protected]

Locations (5)

Find similar trials in Sacramento, CA

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