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

Prostate Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Androgen Antagonists
• Neoadjuvant Therapy
• Prostate Cancer
• Prostatectomy
• Prostatic Neoplasms

• NCT number: NCT03080116
• Study type: Interventional
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Steven Joniau, MD PhD
• Phone: +32 16 34 66 87
• Email: steven.joniau@uzleuven.be
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2019
• Completion date: December 30, 2021