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

Proton Collaborative Group70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

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

Postop High Risk

Proton (prostate bed) to 70.2 CGERADIATION

Salvage Non-High Risk

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

Salvage High Risk

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Proton Center of Arkansas

Little Rock, Arkansas, United States

RECRUITING

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

RECRUITING

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, United States

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

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

Data from ClinicalTrials.gov

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