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

Sponsor

Radiation Therapy Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002602

Collaborator

National Cancer Institute (NCI) (NIH), NRG Oncology (Other)

1,084

Enrollment

228

Locations

Arms

234.1

Duration (Months)

4.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: 3D-CRT	Phase 1/Phase 2

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy to the prostate gland and immediately surrounding tissues in patients with stage II or III adenocarcinoma of the prostate. II. Determine the normal tissue toxicity rate of this regimen in the rectums and bladders of these patients. III. Determine local control by clinical and pathologic examination and by PSA determinations in patients treated with this regimen. IV. Determine the distant failure and overall survival of patients treated with this regimen.

OUTLINE: This is a dose escalation study. Patients are stratified according to 1 of the following 3 prognostic groups: Group 1: T1b-c or T2a-b with combined PSA/Gleason (CPG) score 15 and under Group 2: T1b-c or T2a-b with CPG score more than 15, or any T2c with PSA less than 70 ng/mL Group 3: T3 with prostate specific antigen (PSA) less than 70 ng/mL Patients receive 3-dimensional (3-D) conformal radiotherapy 5 days a week for 7.6, 8.2, or 8.8 weeks. Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 20% of patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 549-801 patients (120-204 patients for the first dose level, 237-321 patients for the second dose level, and 192-276 patients for the third dose level) will be accrued for this study within 4.75 to 5.25 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

1084 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE

Study Start Date :

May 1, 1994

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 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.	Radiation: 3D-CRT 3 dimensional conformal radiation therapy Other Names: 3 dimensional conformal radiation therapy
Experimental: Group 2 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.	Radiation: 3D-CRT 3 dimensional conformal radiation therapy Other Names: 3 dimensional conformal radiation therapy
Experimental: Group 3 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.	Radiation: 3D-CRT 3 dimensional conformal radiation therapy Other Names: 3 dimensional conformal radiation therapy

Arm

Intervention/Treatment

Experimental: Group 1

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.

Radiation: 3D-CRT