Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Study Details
Study Description
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 returned or the risk of prostate cancer returning.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Postop Non-High Risk Proton to 66.6 CGE |
Radiation: Proton to 66.6 CGE
Post-Op Non High Risk
|
Experimental: Postop High Risk IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE |
Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Postop High Risk
|
Experimental: Salvage Non-High Risk Proton to 70.2 CGE |
Radiation: Proton (prostate bed) to 70.2 CGE
Salvage Non-High Risk
|
Experimental: Salvage High Risk IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE |
Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Salvage High Risk
|
Outcome Measures
Primary Outcome Measures
- The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy. [6 months after the end of radiation therapy]
Secondary Outcome Measures
- Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters [After radiation: every 6 months for 3 years, then annually for 20 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
-
Maximum PSA value of 20 ng/ml.
Exclusion Criteria:
-
Evidence of distant metastasis (M1).
-
Prior systemic chemotherapy for any reason.
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Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
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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).
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History of hip replacement.
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Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
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Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Florida Proton Therapy Institute | Jacksonville | Florida | United States | 32206 |
2 | Northwestern Medicine Chicago Proton Center | Warrenville | Illinois | United States | 60555 |
3 | Inova Schar Cancer Institute | Fairfax | Virginia | United States | 22031 |
Sponsors and Collaborators
- Proton Collaborative Group
- University of Florida Health
Investigators
- Principal Investigator: Randal H Henderson, MD, University of Florida Proton Therapy Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- American Cancer Society. 2007. Ref Type: Electronic Citation
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- GU010-18
- UFPTI 0902-PR06