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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Proton to 66.6 CGE; Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE; Radiation: Proton (prostate bed) to 70.2 CGE; Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

• Registration Number: NCT00969111
• Lead Sponsor: Proton Collaborative Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2031-08
• Study Completion: 2050-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postop Non-High Risk	Proton to 66.6 CGE	Proton to 66.6 CGE
Postop High Risk	IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE	IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Salvage Non-High Risk	Proton (prostate bed) to 70.2 CGE	Proton to 70.2 CGE
Salvage High Risk	IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE	IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States

Northwestern Medicine Chicago Proton Center; 🇺🇸 Warrenville, Illinois, United States

Inova Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States