Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments conventional fractionated intensity modulated radiotherapy, hypofractionated intensity modulated radiotherapy
Phase phase 3
Sponsor M.D. Anderson Cancer Center
Start date January 2001
End date January 2018
Trial size 225 participants
Trial identifier NCT00667888, ID00-381, NCI-2010-01456

Summary

The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
conventional fractionated intensity modulated radiotherapy IMRT
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
(Experimental)
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
hypofractionated intensity modulated radiotherapy HIMRT
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Primary Outcomes

Measure
Number of Patients with Incidence of Rising PSA
time frame: 3 months after radiation therapy

Eligibility Criteria

Male participants of any age.

Inclusion Criteria: 1. Biopsy proof of adenocarcinoma of the prostate. 2. Bone scan (If PSA >10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation. 3. CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation. 4. Suitable medical condition; Zubrod <2. 5. Pretreatment PSA 20 ng/ml. 8. Gleason score of 10. 9. Palpable stage T3c (seminal vesicle involvement) or T4 disease.

Additional Information

Official title A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
Principal investigator Deborah A. Kuban, MD
Description Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group. Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center. Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells. Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour. After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence. This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.