Overview

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

Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universitaire Ziekenhuizen Leuven
Criteria
Inclusion Criteria:

1. 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

2. Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations

3. Male aged 18 years or older (within 80 years)

4. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
differentiation or small cell features

5. Diagnosis of intermediate (at least 2 of the following factors: cT2b, biopsy GS 7, PSA
10-20ng/ml) or high-risk prostatic adenocarcinoma (clinical stage≥T2c and/or biopsy
GS≥8 and/or PSA>20ng/ml), cN0-cN1, cM0.

6. Patient amenable for open or robotic radical prostatectomy + pelvic lymph node
dissection

7. ECOG performance status: 0-1

8. 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:

1. Previous surgical/endoscopic treatments for prostatic disease

2. Herbal and non-herbal products that in the opinion of the investigator may decrease
PSA levels

3. cM1 disease

4. Any contraindication for PET or MR investigations

5. 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)

6. Medications known to lower the seizure threshold

7. 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

8. Any other condition that, in the opinion of the Investigator, would impair the
patient's ability to comply with study procedures.