Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

Status:	Active, not recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/31/2018
Start Date:	October 28, 2014
End Date:	October 2019

Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

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.

Inclusion Criteria:

- 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 Criteria:

- 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.

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000