NCT03080116

Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy

Neoadjuvant Degarelix +/- Apalutamide (ARN-509) Followed by Radical Prostatectomy for Intermediate and High-risk Prostate Cancer: a Randomized, Placebo-controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Neoadjuvant hormonal therapy using luteinizing hormone releasing hormone (LHRH) agonists and/or anti-androgens has already demonstrated to downstage primary prostate cancer in patients treated by radical prostatectomy without a survival benefit. There is no evidence yet of a survival impact of LHRH antagonist (LHRHa) +/- new-generation anti-androgens in this setting. Thus novel studies are needed to assess this treatment combination. PURPOSE: To assess the difference in treatment antitumor effect between arms by measuring pathological tumor volume with minimal residual disease (MRD) following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for intermediate or high-risk prostate cancer patients.

Detailed description

PRIMARY OBJECTIVE: To assess the difference in antitumor effect between the treatment arms by measuring MRD following radical prostatectomy. SECONDARY OBJECTIVES: To measure differences between study arms in * Proportions of post neoadjuvant prostate specific antigen (PSA) ≤ 0.3 ng/ml as a predictor of prostate cancer mortality * T down-staging, complete pathological response, PSA kinetics, Testosterone kinetics, operation time, blood loss, grade of surgical difficulty * New generation hybrid imaging 68Ga PSMA (Prostate-Specific Membrane Antigen) PET/MR (Positron emission tomography/Magnetic Resonance) derived parameters * Early biochemical recurrence as prognostic factor of prostate cancer mortality * Transcriptome and genome * Tissue microarrays (TMA) protein expression (DNA repair, resistance etc.) by immunohistochemistry * Perioperative safety and tolerability * Quality of life, erection recovery, continence through validated preoperative and postoperative questionnaires pre and postop (IEEF5, ICIQ, EORTC QLQ-C30) OUTLINE: interventional, single center, phase II, randomized, double blind, placebo controlled trial.

Conditions

• Prostate Cancer
• Neoadjuvant Therapy
• Androgen Antagonists
• Prostatectomy

Interventions

Type	Name	Description
DRUG	ARN-509	240mg/day (4x60mg tablets, Oral administration: OS)
DRUG	Degarelix	1st injection: 120mg Subcutaneous administration (SC) x2, 2nd-3rd SC injection 80mg monthly
OTHER	Placebo	4 tablets, per OS

Timeline

• Start date: 2019-03-28
• Primary completion: 2021-07-01
• Completion: 2024-07-01
• First posted: 2017-03-15
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study