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

Radiation Therapy Oncology Group

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Radiation: High Dose brachytherapy boost

Radiation: External beam radiotherapy

Study type

Interventional

Funder types

Other

NETWORK

NIH

Identifiers

NCT00091390

RTOG-0321

CDR0000382120

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate.

Secondary

Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen.
Determine freedom from biochemical failure in patients treated with this regimen.
Determine overall survival of patients treated with this regimen.
Determine disease-specific survival of patients treated with this regimen.
Determine clinical relapse (local and/or distant) in patients treated with this regimen.
Develop a quality assurance process for high-dose rate prostate brachytherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).

Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.

Enrollment

129 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.