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

Purpose

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.

Condition

  • Prostate Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Postop Non-High Risk 		Proton to 66.6 CGE
  • Radiation: Proton to 66.6 CGE
    Post-Op Non High Risk
Experimental
Postop High Risk 		IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
  • Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
    Postop High Risk
Experimental
Salvage Non-High Risk 		Proton to 70.2 CGE
  • Radiation: Proton (prostate bed) to 70.2 CGE
    Salvage Non-High Risk
Experimental
Salvage High Risk 		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 CGE
    Salvage High Risk

Recruiting Locations

University of Florida Proton Therapy Institute
Jacksonville, Florida 32206
Contact:
Intake Coordinator
877-686-6009

Northwestern Medicine Chicago Proton Center
Warrenville, Illinois 60555
Contact:
Don Smith, MS, CCRC
630-933-7820
donald.smith3@nm.org

Inova Schar Cancer Institute
Fairfax, Virginia 22031
Contact:
Sangeetha Moturi
571-472-0343
sangeetha.moturi@inova.org

More Details

NCT ID
NCT00969111
Status
Recruiting
Sponsor
Proton Collaborative Group