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

NCT00969111 | Recruiting DMC

• 2 other identifiers: GU010-18UFPTI 0902-PR06
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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

Keywords

Proton Radiation, Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.

  6 months after the end of radiation therapy

Secondary Outcomes (1)

• Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters

  After radiation: every 6 months for 3 years, then annually for 20 years

Study Arms (4)

Postop Non-High Risk

EXPERIMENTAL

Proton to 66.6 CGE

Radiation: Proton to 66.6 CGE

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 CGE

Salvage Non-High Risk

EXPERIMENTAL

Proton to 70.2 CGE

Radiation: Proton (prostate bed) to 70.2 CGE

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 CGE

Interventions

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

Postop High Risk

Postop High Risk

Proton (prostate bed) to 70.2 CGE RADIATION

Salvage Non-High Risk

Salvage Non-High Risk

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

Salvage High Risk

Salvage High Risk

Proton to 66.6 CGE RADIATION

Post-Op Non High Risk

Postop Non-High Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
• Maximum PSA value of 20 ng/ml.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Proton Collaborative Group: lead
• University of Florida Health: collaborator

Study Sites (4)

Proton Center of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

RECRUITING

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, 60555, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Related Publications (42)

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Protons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Randal H Henderson, MD

  University of Florida Proton Therapy Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: August 1, 2009
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2050
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (4)