Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)

John Fiveash, MD

Status

Completed

Conditions

Radiation Toxicity

Prostate Adenocarcinoma

Sexual Dysfunction

Prostate Cancer

Treatments

Radiation: Stereotactic Body Radiation Therapy with Integrated Boost

Study type

Interventional

Funder types

Other

Identifiers

NCT01856855

F121218006

Details and patient eligibility

About

This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.

Full description

Objectives:

Primary

-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer

Secondary

Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer
- Determine the treatment planning and dosimetric feasibility
- Evaluate the treatment delivery quality assurance
Clinically assess early efficacy, late toxicity, and quality of life for patients receiving SBRT with integrated boost for clinically localized prostate cancer

Patients will undergo 5 total radiation treatments over 7-17 day period.

Patients will be asked to complete American Urological Association Symptom Index (AUA SI), Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite (EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These questionnaires will be completed at the following time points: Baseline, AUA SI will be collected on the last day of treatment, and every 3 months for the first year following the start of radiation, then every 6 months for year 2.

After completion of study therapy, patients are followed-up every 3 months for the first year, then every 6 months for year 2.

Enrollment

26 patients

Sex

Male

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration
NCCN risk category very low, low, or intermediate risk
Combined Gleason score <7
PSA within three months of enrollment < 20ng/ml
Clinical stage T1a-c N0M0 or clinical stage T2aN0M0
Life expectancy > 5 years
Risk of malignant lymph node involvement < 15% as calculated on Partin tables
Karnofsky performance status (KPS) > 60
Age > 19 years
Subjects given written informed consent

Exclusion criteria

History of inflammatory bowel disease
Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.
Platelet count < 70
Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy).
Risk of malignant lymph node involvement > 15% as calculated on Partin tables.