Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
About This Trial
- This study is testing different types of radiation—including standard radiation and proton beam therapy, sometimes combined with hormone therapy—to treat prostate cancer that has returned or to keep it from coming back.
- It is open to men who have had surgery to remove their prostate, have a PSA level of 20 or lower, and whose cancer has not spread to distant parts of the body.
- You may not be able to join if you have had prior chemotherapy, previous radiation to your pelvic area, or active bowel disease affecting the rectum.
- Additionally, participants must be willing to pause taking certain medications and herbal supplements, such as Saw Palmetto, during radiation treatment.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing different types of radiation—including standard radiation and proton beam therapy, sometimes combined with hormone therapy—to treat prostate cancer that has returned or to keep it from coming back.
Study Details
- Start Date: August 2009
- Lead Sponsor: Proton Collaborative Group
Full Eligibility 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.
- 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).
- 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.
Treatments
- 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