Status:
RECRUITING
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Lead Sponsor:
Proton Collaborative Group
Collaborating Sponsors:
University of Florida Health
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 returne...
Eligibility Criteria
Inclusion
- Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
- Maximum PSA value of 20 ng/ml.
Exclusion
- Evidence of distant metastasis (M1).
- Prior systemic chemotherapy for any reason.
- Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
- 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).
- History of hip replacement.
- Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2050
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00969111
Start Date
August 1 2009
End Date
August 1 2050
Last Update
September 9 2025
Active Locations (4)
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1
Proton Center of Arkansas
Little Rock, Arkansas, United States, 72205
2
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
3
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States, 60555
4
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031