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8110 Gatehouse Road, Falls Church, VA 22042

A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation with Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate (PCG - GU002-10)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT01230866

Background Information

One of the standard treatment options for certain stages and types of prostate cancer is external beam radiation therapy using protons. Recent studies have shown improved disease control when higher daily doses of radiation are given. The purpose of this study is to compare the effects (good and bad) of 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. This treatment change is “investigational.” “Investigational” means it has not been approved as a standard of care treatment.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • 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
  • PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy
  • 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.

Ineligibility Information

  • Previous prostate cancer surgery including: 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)
  • 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.