Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

Phase III Study of Image Guided Radiation Therapy with or without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate (PCG - GU003-10)

Translate

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT01492972

Background Information

Radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination of radiation therapy with androgen suppression therapy is not completely understood. The purpose of this study is to compare the effects, good and/or bad of two treatment methods.

Prostate cancer feeds on male hormones, such as testosterone. Drugs that reduce or block testosterone (hormone therapy) can cause some prostate cancer cells to die and others to stop growing. Some patients with high risk prostate cancer treated with a combination of these drugs and radiation have a greater chance of not having the cancer return when compared to men treated with radiation alone. Since the extent of the potential benefit of hormone suppression for intermediate risk patients is not completely defined, the benefit of combining hormone therapy with radiation therapy needs to be tested.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • 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
  • ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization
  • Patients must be at least 18 years old
  • For brachytherapy, an IPSS ≤ 21, or ≤ 17 if the patient is on medications to improve urination
  • For brachytherapy, prostate volume must be less than 55cc prior to AS
  • Additional eligibility in Protocol

Ineligibility Information

  • 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)
  • History of myocardial infarction within the last 6 months
  • Additional ineligibility in protocol

Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT01492972