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

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer. Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Trial Details

NCT ID
NCT01492972
Phase
PHASE3
Sponsor
Proton Collaborative Group
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Radiation
  • Androgen Suppression Therapy
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Warrenville, Illinois, United States|41.81781,-88.1734
  • Oklahoma City, Oklahoma, United States|35.46756,-97.51643
  • Hampton, Virginia, United States|37.02987,-76.34522

Key Eligibility Criteria

  • Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least on…
  • 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. \>…
  • PSA values \< = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Prostate Cancer Trials on Trialify →