Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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 radiation dose with each treatment over a shorter period of time.
Key facts
- Study ID
- NCT02280356
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 45
- Starts
- 2014-10-28
- Expected to finish
- 2023-01-09
- Last updated by the study team
- 2024-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
- Memorial Sloan Kettering Westchester — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York, United States
- Memorial Sloan Kettering Nassau (Follow Up Only) — Uniondale, New York, United States
Full record on ClinicalTrials.gov
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