Recruiting

Proton Radiation & Conventional Radiation

Sponsor:

Proton Collaborative Group

Code:

NCT00969111

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

Proton (prostate bed) to 70.2 CGE

IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Proton to 66.6 CGE

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT00969111

Start date

Aug, 2009

Status verified date

Sep, 2025

Completion date

Aug, 2050

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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).
  • 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

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Postop Non-High Risk

Proton to 66.6 CGE

experimental: Postop High Risk

IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

experimental: Salvage Non-High Risk

Proton to 70.2 CGE

experimental: Salvage High Risk

IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Interventions

IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

Postop High Risk

Proton (prostate bed) to 70.2 CGE

Salvage Non-High Risk

IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Salvage High Risk

Proton to 66.6 CGE

Post-Op Non High Risk

Primary outcome measure

  • The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy. [ Time Frame: 6 months after the end of radiation therapy ]

Central Contacts and Locations

Locations

Proton Center of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Monica Coleman

501-686-8274mmcoleman@uams.edu

Principal Investigator:

Sanjay Maraboyina, MD

University of Florida Proton Therapy Institute

Recruiting

Jacksonville, Florida, United States, 32206

Contacts

Intake Coordinator

877-686-6009

Principal Investigator:

Samuel Jean-Baptiste, MD

Northwestern Medicine Chicago Proton Center

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Don Smith, MS, CCRC

630-933-7820donald.smith3@nm.org

Principal Investigator:

Arpi Thukral, MD

McLaren Proton Therapy Center

Recruiting

Flint, Michigan, United States, 48532

Contacts

Stacy Freeman

313-576-8495freemans@karmanos.org

Principal Investigator:

Brian Yeh, MD

Mercy David C. Pratt Cancer Center

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Nancy Umbeck

314-251-7066nancy.umbeck@mercy.net

Principal Investigator:

Amit Roy, MD

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Sangeetha Moturi

571-472-0343sangeetha.moturi@inova.org

Principal Investigator:

Kevin Choe, MD

More Information

Sponsor

Proton Collaborative Group

Last update posted

Jun 17, 2026

Last verified

Sep, 2025

Keywords

  • Proton Radiation, Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Proton Collaborative Group on 2026-06-17.