Clinical Trials /

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

NCT00969111

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
  • Official Title: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: GU010-18
  • SECONDARY ID: UFPTI 0902-PR06
  • NCT ID: NCT00969111

Conditions

  • Prostate Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Postop Non-High RiskExperimentalProton to 66.6 CGE
    Postop High RiskExperimentalIMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
      Salvage Non-High RiskExperimentalProton to 70.2 CGE
        Salvage High RiskExperimentalIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

          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.
                
          Maximum Eligible Age:N/A
          Minimum Eligible Age:18 Years
          Eligible Gender:Male
          Healthy Volunteers:No

          Primary Outcome Measures

          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
          Safety Issue:
          Description:

          Secondary Outcome Measures

          Measure: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
          Safety Issue:
          Description:

          Details

          Phase:N/A
          Primary Purpose:Interventional
          Overall Status:Recruiting
          Lead Sponsor:Proton Collaborative Group

          Trial Keywords

          • Proton Radiation, Prostate Cancer

          Last Updated

          July 10, 2019