A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate

Proton Collaborative Group5 sites in 1 country150 target enrollmentNovember 1, 2010

ConditionsProstate Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Proton Collaborative Group
Enrollment: 150
Locations: 5
Primary Endpoint: To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
Status: Active, Not Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

Registry

clinicaltrials.gov

Start Date

November 1, 2010

End Date

December 2027

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Proton Collaborative Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
•History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
•Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-
•\> 6 cores are strongly recommended.
•PSA values \< 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
•Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
•No pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
•Patients must be at least 18 years old.
•ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
•IPSS score \<=

Exclusion Criteria

•Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
•Previous pelvic radiation for prostate cancer.
•Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.
•Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
•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, to have a biopsy if needed, or for marker placement).
•Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in 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).

Outcomes

Primary Outcomes

To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.

Time Frame: At 5 years post treatment completion +/- 90 days

The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation.