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.
Recruiting
N/A
| Name | Type | Description | Interventions |
|---|---|---|---|
| Postop Non-High Risk | Experimental | Proton to 66.6 CGE | |
| Postop High Risk | Experimental | IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE | |
| Salvage Non-High Risk | Experimental | Proton to 70.2 CGE | |
| Salvage High Risk | Experimental | IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE |
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
| Measure: | The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy. |
| Time Frame: | 6 months after the end of radiation therapy |
| Safety Issue: | |
| Description: |
| Measure: | Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters |
| Time Frame: | After radiation: every 6 months for 3 years, then annually for 20 years |
| Safety Issue: | |
| Description: |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Proton Collaborative Group |
July 12, 2019
