Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Official record

Identifier

NCT01492972

Recruiting locations

country

United States

Interventions studied

RadiationAndrogen Suppression Therapy

Lead sponsor

Proton Collaborative Group

Target enrolment

192 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Dec 15, 2011

Last updated on the registry

Sep 29, 2026

Age

18 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA \> = 10 and \< = 20, T stage T2b - T2c
* Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. \> 6 cores are strongly recommended.
* PSA values \< = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
* ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
* Patients must sign IRB approved study specific informed consent.
* Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
* Patients must be able to start treatment within 56 days of randomization.
* Patients must be at least 18 years old.
* For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
* For brachytherapy, prostate volume must be less than 55cc prior to AS.

Exclusion Criteria:

* Pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
* Previous pelvic radiation for prostate cancer.
* Previous androgen suppression therapy for prostate cancer.
* Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
* Prior systemic chemotherapy for prostate cancer.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
* Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
* Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
* History of myocardial infarction within the last 6 months.

Indexed under

Prostate Cancer