Phase 2
Completed N=108
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Source: ClinicalTrials.gov NCT04523207 ↗Enrolled (actual)
108
Serious AEs
13.3%
Results posted
Nov 2024
Primary outcomePrimary: Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24 — 100 Percentage of participants
Summary
Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate.
Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24 |
100 | — |
| PRIMARY Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28 |
100 | — |
| SECONDARY Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12 |
100 | — |
| SECONDARY Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24 |
42.0; 77.4 | — |
| SECONDARY Sub-study: Number of Participants With Treatment-emergent Adverse Events |
8 | — |
Eligibility Criteria
Inclusion Criteria
- A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of =) 20 ng/ml or; Gleason Score >= 9 in any core on biopsy or; Gleason Score >= 8 (4+4 or 5+3) in greater than (>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy
Exclusion Criteria
- History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (<) 2 centimeter (cm) in diameter [short axis] either radiographically or pathologically are allowed.)
- History of bilateral orchiectomy
- Received an investigational intervention <= 4 weeks before the planned first dose of study intervention
- History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
- Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)
Data sourced from ClinicalTrials.gov (NCT04523207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.