Print

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 4160021, Florida 4155751 32206
Contact:
Intake Coordinator
877-686-6009

Northwestern Medicine Chicago Proton Center
Warrenville 4915525, Illinois 4896861 60555
Contact:
Don Smith, MS, CCRC
630-933-7820
donald.smith3@nm.org

Inova Schar Cancer Institute
Fairfax 4758023, Virginia 6254928 22031
Contact:
Sangeetha Moturi
571-472-0343
sangeetha.moturi@inova.org

More Details

NCT ID
NCT00969111
Status
Recruiting
Sponsor
Proton Collaborative Group

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.