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

Completed · Not applicable

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity, Sexual Dysfunction

In brief

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.

Key facts

Study ID

NCT01856855

Run by

John Fiveash, MD

People needed

26

Starts

2013-02-01

Expected to finish

2022-12-01

Last updated by the study team

2023-01-12

Who can join

Age: 19 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hazelrig-Salter Radiation Oncology Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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