Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer
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.
Conditions:
🦠 Prostate Cancer
🗓️ Study Start (Actual) January 2014
🗓️ Primary Completion (Estimated) December 2019
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 235
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Knoxville, Tennessee, United States
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 January 2014
  • First Submitted that Met QC Criteria 16 January 2014
  • First Posted 20 January 2014

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 April 2019
  • Last Update Posted 5 April 2019
  • Last Verified April 2019