Status:
COMPLETED
Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher rad...
Eligibility Criteria
Inclusion
- Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
- Pathologically-proven diagnosis of prostate adenocarcinoma
- PSA 10-20ng/mL or
- Gleason =7 or
- Clinical stage T2b/c
- Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
- Age ≥18
- KPS≥70
- Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
- International Prostate Symptom Score ≤15
Exclusion
- Prior prostate surgery (including TURP)
- Prior history of chronic prostatitis or urethral stricture
- Inflammatory bowel disease
- Prior history of pelvic radiotherapy
- Unable to give informed consent
- Metastatic disease.
Key Trial Info
Start Date :
October 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02280356
Start Date
October 28 2014
End Date
January 9 2023
Last Update
March 4 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065