Clinical Trials /

Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer

NCT02040610

Description:

This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer
  • Official Title: A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: PRO 1401
  • NCT ID: NCT02040610
  • NCT ALIAS: NCT02198222

Conditions

  • Prostate Cancer

Purpose

This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.

Detailed Description

      Patients will receive: 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
    

Trial Arms

NameTypeDescriptionInterventions
Low Risk Prostate CancerActive ComparatorHypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
    Intermediate Risk Prostate CancerActive ComparatorHypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Pathological (histologically) proven diagnosis of prostatic adenocarcinoma within 365
                   days (1 year) prior to study registration.
      
                     -  History and physical exam with digital rectal exam of the prostate to establish
                        clinical staging
      
                     -  Clinical stage T1-T2c (AJCC 7th edition) within 90 days of registration.
      
                     -  Prostate specific antigen (PSA) < 20 ng/mL within 90 days prior to registration.
      
                     -  Gleason Score < 7.
      
                     -  Eastern Cooperative Oncology Group(ECOG) Performance status 0-1.
      
                     -  Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or
                        MRI scan).
      
                     -  Patients with lymph nodes equivocal or questionable by imaging are eligible
                        without biopsy if the nodes are ≤ 1.5 cm in diameter; any node larger than this
                        on imaging will require negative biopsy for eligibility, unless the node is know
                        to be enlarged from prior scans and considered stable, per discretion of the
                        treating physician.
      
                     -  Patients must be 18 years of age or older.
      
                     -  Patient must be able to provide study-specific informed consent prior to study
                        entry.
      
                     -  Willingness and ability to complete the Expanded Prostate Cancer Index Composite
                        (EPIC) Questionnaire.
      
                     -  No evidence of bone metastases (M0) on bone scan within 60 days prior to
                        registration.
      
                     -  Bone scan is not required for patients enrolled with a single intermediate risk
                        factor only, but this scan may be obtained at the discretion of the treating
                        physician. Patients with 2 or 3 risk factors will require a negative bone scan
                        for eligibility.
      
                     -  Equivocal bone scan findings are allowed if plain film x-rays are negative for
                        metastasis.
      
                     -  Patient is able to start proton therapy or neo-adjuvant hormonal therapy, when
                        recommended, within 12 weeks of registration.
      
                     -  No prior radiotherapy to the pelvic area.
      
                     -  No prior prostate cancer therapy such as: prostatectomy, cryotherapy,
                        chemotherapy or hyperthermia.
      
                     -  Platelets ≥ 100,000 cells/mm3, Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3,
                        Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to
                        achieve Hgb ≥ 8.0 g/dl is acceptable.)
      
                     -  Obs.: Patients with high risk factors, such as T3, Gleason 8-10 or PSA > 20ng/mL
                        who are not considered candidates for pelvic lymph node radiation treatment are
                        still considered eligible for this study.
      
              Exclusion Criteria:
      
                -  • Prior radiotherapy to the pelvic area.
      
                     -  Prior prostate cancer therapy such as: prostatectomy, cryotherapy, or
                        hyperthermia.
      
                     -  Prior systemic therapy (chemotherapy) for prostate cancer.
      
                     -  Evidence of distant metastases.
      
                     -  Regional lymph node involvement.
      
                     -  Previous or concurrent cytotoxic chemotherapy for prostate cancer.
      
                     -  Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease
                        Control (CDC) definition. Note however, that HIV testing is not required for
                        entry into this protocol. The need to exclude patients with AIDS from this
                        protocol is necessary because the treatments involved in this protocol may be
                        significantly immunosuppressive. Protocol-specific requirements may also exclude
                        immune-compromised patients.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Time to biochemical failure
      Time Frame:5 years
      Safety Issue:
      Description:To determine the freedom from biochemical failure survival outcomes (FFBF) and compare to historical FFBF results achieved following standard fractionation proton therapy

      Secondary Outcome Measures

      Measure:Toxicity Assessment
      Time Frame:2 years & 5 years
      Safety Issue:
      Description:To determine the incidence of acute and late Gastrointestinal and Genitourinary toxicity at 2 and 5 years.
      Measure:Analyze Quality of Life
      Time Frame:2 years & 5 years
      Safety Issue:
      Description:To assess quality of life following proton therapy (QOL EPIC) at 2 and 5 years

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Provision Center for Proton Therapy

      Trial Keywords

      • Low Risk Prostate Cancer
      • Intermediate Risk Prostate Cancer
      • Hypofractionated
      • Image Guided Proton Therapy

      Last Updated

      April 3, 2019