Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
70Conditions
Prostate CancerSummary
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.
Locations
3 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Intake Coordinator
- 877-686-6009
Principal Investigator
- Randal H Henderson, MD
Status
- RECRUITING
Contact Person
- Don Smith, MS, CCRC
- 630-933-7820
- [email protected]
Principal Investigator
- Randal H Henderson, MD
Status
- RECRUITING
Contact Person
- Sangeetha Moturi
- 571-472-0343
- [email protected]
Principal Investigator
- Randal H Henderson, MD
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.
Study Plan
Postop Non-High Risk
EXPERIMENTAL
Proton to 66.6 CGE
RADIATION:
Proton to 66.6 CGEDescription:
Post-Op Non High Risk
Postop High Risk
EXPERIMENTAL
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
RADIATION:
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGEDescription:
Postop High Risk
Salvage Non-High Risk
EXPERIMENTAL
Proton to 70.2 CGE
RADIATION:
Proton (prostate bed) to 70.2 CGEDescription:
Salvage Non-High Risk
Salvage High Risk
EXPERIMENTAL
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 CGEDescription:
Salvage High Risk
Outcome Measures
Primary Outcome Measures
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Secondary Outcome Measures
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters
Timeline
Last Updated
June 3, 2024Start Date
August 31, 2009Today
January 16, 2025Completion Date ( Estimated )
August 1, 2050
Sponsors of this trial
Lead Sponsor
Proton Collaborative GroupCollaborating Sponsors
University of Florida Health
RECRUITING 
21 - 64 Years