Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

Proton Collaborative Group

Status and phase

Active, not recruiting

Phase 3

Conditions

Prostate Cancer

Treatments

Radiation: Proton Radiation Standard Fractionation

Radiation: Proton Radiation Hypofractionation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01230866

GU002-10

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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. > 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 <= 16.
Patients must give IRB approved, study specific, informed consent.
Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
Patients must be able to start treatment within 56 days of randomization.

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).