At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate, stage T1c-T2b, N0, M0
- ✓Intermediate-risk disease: Gleason score <7 AND PSA 10-20 ng/mL, OR Gleason score 7 AND PSA <10 ng/mL
- ✓Prostate volume ≤60 cc by transrectal ultrasonography
- ✓American Urological Association voiding symptom score ≤15
- ✕Evidence of distant metastases
- ✕Prior pelvic radiotherapy
- ✕Prior radical surgery for prostate cancer
- ✕Prior transurethral resection of the prostate (TURP)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma
In Brief
A Phase 3 clinical trial evaluating Brachytherapy (100/110), Brachytherapy (125/145), and 1 other intervention for Prostate Cancer. Completed, enrolled 588 participants across 170 sites in 2 countries.
Detailed Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
Study Details
Timeline
Interventions
100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.
125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.
Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.