Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
* Radiation: Proton (prostate bed) to 70.2 CGE
* Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
* Radiation: Proton to 66.6 CGE


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postop Non-High Risk<br>Proton to 66.6 CGE | Radiation: Proton to 66.6 CGE<br>* Post-Op Non High Risk<br>|
| Experimental: Postop High Risk<br>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<br>* Postop High Risk<br>|
| Experimental: Salvage Non-High Risk<br>Proton to 70.2 CGE | Radiation: Proton (prostate bed) to 70.2 CGE<br>* Salvage Non-High Risk<br>|
| Experimental: Salvage High Risk<br>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<br>* Salvage High Risk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton Radiation, Prostate Cancer