Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.

Key facts

Study ID

NCT00091390

Run by

Radiation Therapy Oncology Group

People needed

129

Starts

2004-07-01

Expected to finish

2016-12-01

Last updated by the study team

2020-08-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0.
• Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
• The patient will be clinically M0.
• Zubrod status 0-1.
• No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable.
• One of the following combinations of factors:
• Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) >10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20
• Patients must sign a study-specific consent form prior to registration.

You may not qualify if…

• Stage T4 disease.
• Lymph node involvement (N1).
• Evidence of distant metastases (M1).
• Radical surgery for carcinoma of the prostate.
• Previous hormonal therapy beginning > 120 days prior to registration.
• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
• Prior transurethral resection of the prostate (TURP).
• Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
• Hip prosthesis.

Where it is running

• Providence Saint Joseph Medical Center - Burbank — Burbank, California, United States
• Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital — Inglewood, California, United States
• Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
• University of Colorado Cancer Center at University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center — Boca Raton, Florida, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Maine Center for Cancer Medicine and Blood Disorders - Scarborough — Scarborough, Maine, United States
• William Beaumont Hospital - Royal Oak Campus — Royal Oak, Michigan, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Fletcher Allen Health Care - University Health Center Campus — Burlington, Vermont, United States
• Waukesha Memorial Hospital Regional Cancer Center — Waukesha, Wisconsin, United States

Full record on ClinicalTrials.gov

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