Protocol Summary

Protocol No.: OCR10959

Sponsor Protocol No.: PR06

Study Title
UFPTI 0902-PR06: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Principal Investigator(s)
Henderson, Randal

Objective
The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

Description
This study aims to examine the treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.

Phase: Phase II (Cancer Control)

Age Group: Adult

Scope: Local

Treatment
POSTOP NON-HIGH RISK: 66.6 CGE to prostate bed

POSTOP HIGH RISK: 45 Gy to whole pelvis followed by 21.6 CGE to prostate bed and hormonal therapy encouraged

SALVAGE HIGH RISK: 45 Gy to whole pelvis followed by 25.2 CGE to prostate bed, if image indicated an additional 3.6 CGE and hormonal therapy encouraged

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years-old and older.
2. Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
3. Maximum PSA value of 20 ng/ml.

EXCLUSION CRITERIA:
1. Evidence of distant metastasis (M1).
2. Prior systemic chemotherapy for any reason.
3. Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
4. Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
5. History of hip replacement.
6. Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
7. Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Applicable Disease Sites
Prostate Cancer

Therapies Involved
Hormonal Therapy
Radiotherapy

Participating Institutions
UF Jacksonville : Judy Holland

Contact
Judy Holland
Phone: +1 877-686-6009

Email: jholland@floridaproton.org

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT00969111