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

Recruiting in Palo Alto (17 mi)

+227 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer.

Research Team

James D. Cox, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven regional nodal involvement No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior pelvic irradiation Surgery: No prior prostatectomy or cryosurgery for prostate cance

Treatment Details

Interventions

3D-CRT (Radiation Therapy)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Group 3Experimental Treatment1 Intervention

Clinical stage T3 with PSA \< 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.

Group II: Group 2Experimental Treatment1 Intervention

Clinical stages T1b-c or T2a-b with PSA + (\[Gleason -6\]x10)\>15. Any clinical T2c with PSA \< 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.

Group III: Group 1Experimental Treatment1 Intervention

Clinical stages T1b-c or T2a-b with PSA + (\[Gleason -6\] x 10) is ≤ 15. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.