A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer

Provision Center for Proton Therapy2 sites in 1 country235 target enrollmentJanuary 2014

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Provision Center for Proton Therapy
Enrollment: 235
Locations: 2
Primary Endpoint: Time to biochemical failure
Status: Recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

December 2025

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Provision Center for Proton Therapy

Responsible Party

Sponsor

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 \<
•Eastern Cooperative Oncology Group(ECOG) Performance status 0-
•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.

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.

Outcomes

Primary Outcomes

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