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

Proton Collaborative Group4 sites in 1 country70 target enrollmentAugust 1, 2009

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Proton Collaborative Group
Enrollment: 70
Locations: 4
Primary Endpoint: The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2009

End Date

August 1, 2050

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Proton Collaborative Group

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)