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Neoadjuvant and Adjuvant Abiraterone + Apalutamide in Prostate Cancer
NCT02903368Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2016
- Primary completion
- Apr 2022
- Countries
- 1
- Sponsor
- Dana-Farber Cancer Institute
- Modality
- Orthosteric Ligands
- Drugs
- apalutamide
- Conditions
- Prostate Adenocarcinoma (PRAD)
01
Overview
Phase 2, randomised, open-label trial of apalutamide in Prostate Adenocarcinoma (PRAD) (4 arms), sponsored by Dana-Farber Cancer Institute. Primary endpoints: Combined Pathologic Complete Response or Minimum Residual Disease Rate at 6 months and Biochemical Progression Free Survival Rate at 3 years. Started Oct 2016; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
AAPL Neoadjuvant
Abiraterone + Apalutamide + Leuprolide + Prednisone for 6 months
APL Neoadjuvant
Abiraterone + Leuprolide + Prednisone for 6 months
AAPL Adjuvant
Abiraterone + Apalutamide + Leuprolide + Prednisone for 12 months
Observation
Observation for 12 months
03
Who it enrols
Men with intermediate-high risk prostate cancer (Gleason >= 7, PSA > 20 or T3) who are candidates for radical prostatectomy.
04
Endpoints
Primary
Combined Pathologic Complete Response or Minimum Residual Disease Rate
Biochemical Progression Free Survival Rate
Secondary
Rate of Pathologic Complete Response at RP
Median of Residual Cancer Burden at RP
Frequency of Presenting Cribriform at RP
Frequency of Presenting Intraductal Carcinoma at RP
Frequency of Positive Surgical Margins at RP
Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP
Frequency of Presenting Intra-operative Complications Following RP
Biochemical Progression Free Survival Rate
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