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

Launched by PROTON COLLABORATIVE GROUP · Aug 28, 2009

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different types of radiation therapy (specifically proton radiation and conventional radiation) and hormonal therapy for men with prostate cancer that has come back after surgery or who are at risk of it returning. The goal is to understand both the benefits and any side effects of these treatments.

To participate in the trial, men aged 65 to 74 who have had surgery for prostate cancer and have a maximum PSA level of 20 ng/ml may be eligible. However, those with certain conditions, like advanced cancer that has spread to other parts of the body, previous chemotherapy, or specific inflammatory bowel diseases, cannot participate. If you join the trial, you can expect to receive either proton or conventional radiation as part of your treatment plan and will be monitored closely for how well the treatment works and any side effects you may experience.

Gender

MALE

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).
• • 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.