Proton and conventional radiation for prostate cancer after surgery
Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
This study is testing whether proton radiation or conventional radiation with hormone therapy can help men with recurring prostate cancer after surgery feel better and improve their chances of recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Proton Collaborative Group Research network |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 4 sites (Little Rock, Arkansas and 3 other locations) |
| Trial ID | NCT00969111 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of proton radiation and conventional radiation combined with hormonal therapy on prostate cancer that has recurred or has a risk of returning after radical prostatectomy. Patients will receive various radiation treatments, including intensity-modulated radiation therapy (IMRT) and proton boosts to the prostate bed. The study aims to evaluate both the positive and negative effects of these treatments on prostate cancer outcomes.
Who should consider this trial
Good fit: Ideal candidates are men who have undergone radical prostatectomy for prostate cancer and have a maximum PSA value of 20 ng/ml.
Not a fit: Patients with evidence of distant metastasis, prior systemic chemotherapy, or active inflammatory bowel disease affecting the rectum may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with recurrent prostate cancer, potentially improving their prognosis.
How similar studies have performed: Other studies have shown promise with proton therapy for prostate cancer, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Little Rock, Arkansas and 3 other locations
- Proton Center of Arkansas — Little Rock, Arkansas, United States (Recruiting)
- University of Florida Proton Therapy Institute — Jacksonville, Florida, United States (Recruiting)
- Northwestern Medicine Chicago Proton Center — Warrenville, Illinois, United States (Recruiting)
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Randal H Henderson, MD — University of Florida
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.