Radiotherapy and 6-month androgen deprivation therapy with or without apalutamide in Intermediate and Limited High Risk Localized Prostate Cancer: a phase III study

European Organisation for Research and Treatment of Cancer (EORTC)0 sites990 target enrollmentOctober 11, 2019

Overview

No summary available.

Registry

who.int

Start Date

October 11, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

European Organisation for Research and Treatment of Cancer (EORTC)

•Histologically confirmed diagnosis of prostate adenocarcinoma diagnosed by ultrasound guided biopsy of the prostate containing 10\-12 cores showing no neuroendocrine component at local institution. (An MRI\-fusion biopsy is allowed if taken because a previous biopsy was negative.)
•PSA \- Favorable intermediate risk :
•\- Only one of the following intermediate risk factors: PSA 10\-20 ng/mL, or Gleason score 7 (3\+4\) (international society of urological pathology\-ISUP Grade 2\), or cT2b
•\- Unfavorable intermediate risk :
•\- either PSA 10\-20 ng/mL and cT2b,
•\- or Gleason score 7 (4\+3\) (ISUP Grade 3\)
•\- Limited high risk: 20 ng/mL or Gleason score \>7 (ISUP Grade 4/5\)
•M0 by standard imaging work\-up
•Scheduled to be treated with primary prostate RT
•ECOG/WHO Performance Status \= 2

•cT2c, T3, T4 or pelvic lymph nodes involvement, as assessed by CT scan or MRI (cN1\) or pelvic lymph node dissection (pN1\)
•Previous pelvic irradiation or radical prostatectomy.
•Bilateral orchiectomy
•Prior systemic (e.g., chemotherapy) or procedural (e.g., prostatectomy, cryotherapy) treatment for prostate cancer
•Prior treatment with 5\-alpha reductase inhibitors for benign prostatic hypertrophy not discontinued 4 weeks prior to randomization
•Prior treatment with any LHRH agonist or antagonist, bicalutamide, flutamide or nilutamide, enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer
•Prior treatment with radiopharmaceutical agents (e.g., strontium\-89\) or immunotherapy for prostate cancer
•Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has no evidence of disease for at least 5 years.
•History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, systemic lupus erythematosus or Fanconi anemia
•History of seizure or condition that may predispose to seizure (including but not limited to: a) prior stroke, transient ischemic attack or loss of consciousness, any of which occurred \= 1 year prior to randomization; b) brain arteriovenous malformation; or c) intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).