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Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Provision Center for Proton Therapy
Sponsor:
Collaborator:
Center for Biomedical Research, LLC
Information provided by (Responsible Party):
Provision Center for Proton Therapy
ClinicalTrials.gov Identifier:
NCT02040610
First received: January 16, 2014
Last updated: October 24, 2016
Last verified: October 2016
  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.

Condition Intervention Phase
Prostate Cancer
Radiation: Hypofractionated Proton Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Provision Center for Proton Therapy:

Primary Outcome Measures:
  • Time to biochemical failure [ Time Frame: 5 years ]
    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:
  • Toxicity Assessment [ Time Frame: 2 years & 5 years ]
    To determine the incidence of acute and late Gastrointestinal and Genitourinary toxicity at 2 and 5 years.

  • Analyze Quality of Life [ Time Frame: 2 years & 5 years ]
    To assess quality of life following proton therapy (QOL EPIC) at 2 and 5 years


Other Outcome Measures:
  • Salvage Androgen Deprivation Therapy [ Time Frame: Every 6 months for 5 years ]
    To determine the need for salvage Androgen Deprivation Therapy for biochemical or other relapse events


Estimated Enrollment: 235
Study Start Date: January 2014
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Risk Prostate Cancer
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Radiation: Hypofractionated Proton Therapy
Other Name: Proton Therapy
Active Comparator: Intermediate Risk Prostate Cancer
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Radiation: Hypofractionated Proton Therapy
Other Name: Proton Therapy

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02040610

Contacts
Contact: Kristi Simcox, BS, CCRP 865-243-3279 ksimcox@biomed-research.com
Contact: Susie Owenby, RN, CCRP 865-934-2672 sowenby@biomed-research.com

Locations
United States, Tennessee
Provision Center for Proton Therapy Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Kristi Simcox, BS, CCRP    865-243-3279    ksimcox@biomed-research.com   
Contact: Susie Owenby, RN, CCRP    865-934-2672    sowenby@biomed-research.com   
Principal Investigator: Marcio Fugundes, M.D.         
Sub-Investigator: Allen Meek, M.D.         
Sponsors and Collaborators
Provision Center for Proton Therapy
Center for Biomedical Research, LLC
Investigators
Principal Investigator: Marcio Fagundes, M.D. Provision Center for Proton Therapy
  More Information

Responsible Party: Provision Center for Proton Therapy
ClinicalTrials.gov Identifier: NCT02040610     History of Changes
Obsolete Identifiers: NCT02198222
Other Study ID Numbers: PRO 1401 
Study First Received: January 16, 2014
Last Updated: October 24, 2016

Keywords provided by Provision Center for Proton Therapy:
Low Risk Prostate Cancer
Intermediate Risk Prostate Cancer
Hypofractionated
Image Guided Proton Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 20, 2017