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


Condition: Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity, Sexual Dysfunction

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01856855

Sponsor: John Fiveash, MD

Eligibility:

  • Age: minimum 19 Years maximum N/A
  • Gender: Male

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:

  • 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.

View trial on ClinicalTrials.gov