Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer

April 3, 2019 updated by: Provision Center for Proton Therapy

A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Proton Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years & 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
2 years & 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 6 months for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Provision Center for Proton Therapy

Collaborators

Center for Biomedical Research, LLC

Investigators

  • Principal Investigator: J. Ben Wilkinson, M.D., Provision Center for Proton Therapy

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 Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO 1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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