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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    84
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 27 January 2021
platelet count
prostatectomy
gonadotropin
androgens
endocrine therapy
hormone therapy
antiandrogen therapy
antiandrogens
degarelix
luteinizing hormone
apalutamide
adenocarcinoma
adenocarcinoma of prostate
gonadorelin
arn-509

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.

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.

Details
Condition Malignant neoplasm of prostate, Neoadjuvant Therapy, Antiandrogens, Prostatic disorder, Prostatectomy, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, induction therapy, neoadjuvant treatment, prostate cancers, antiandrogen therapy, anti-androgens, anti-androgen, antiandrogen
Treatment Placebo, Degarelix, ARN-509
Clinical Study IdentifierNCT03080116
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Are you male?
Do you have any of these conditions: Prostatectomy or Antiandrogens or Neoadjuvant Therapy or Malignant neoplasm of prostate?
Do you have any of these conditions: prostate cancers or Antiandrogens or Prostate Disorders or Malignant neoplasm of prostate or Prostatic disorder or antiandrogen or Prostate Cancer or ...?
Do you have any of these conditions: Malignant neoplasm of prostate or prostate cancers or Neoadjuvant Therapy or Prostatic disorder or Prostate Disorders or antiandrogen therapy or anti-...?
Do you have any of these conditions: Antiandrogens or neoadjuvant treatment or Prostate Cancer or Prostate Cancer, Early, Recurrent or anti-androgen or Malignant neoplasm of prostate or a...?
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
Male aged 18 years or older (within 80 years)
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Diagnosis of intermediate (at least 2 of the following factors: cT2b, biopsy GS 7, PSA 10-20ng/ml) or high-risk prostatic adenocarcinoma (clinical stageT2c and/or biopsy GS8 and/or PSA>20ng/ml), cN0-cN1, cM0
Patient amenable for open or robotic radical prostatectomy + pelvic lymph node dissection
ECOG performance status: 0-1
Adequate organ function as defined by the following criteria
White blood cells (WBC) 4.0 x109/L
Platelet count 100 x109/L
Hemoglobin 9 g/dl
Creatinine 2 x ULN
Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) 2.5 x upper limit of normality (ULN)
Total serum bilirubin 1.5 x ULN

Exclusion Criteria

Previous surgical/endoscopic treatments for prostatic disease
Herbal and non-herbal products that in the opinion of the investigator may decrease PSA levels
cM1 disease
Any contraindication for PET or MR investigations
History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
Medications known to lower the seizure threshold
History of
Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer currently in complete remission) within 5 years prior to randomization
Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
Uncontrolled hypertension (systolic blood pressure 160 mmHg or diastolic BP 100 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Gastrointestinal disorder affecting absorption
Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
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