Clinical Trials Logo

Clinical Trial Summary

This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and may have fewer side effects than standard radiation therapy.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (< 90 days). SECONDARY OBJECTIVES: I. To describe the acute (< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting. II. To describe the late (> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting. TERTIARY OBJECTIVES: I. To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment. OUTLINE: This is a dose-escalation study. Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks. After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02446366
Study type Interventional
Source University of Southern California
Contact
Status Active, not recruiting
Phase N/A
Start date May 12, 2015
Completion date February 12, 2023

See also
  Status Clinical Trial Phase
Completed NCT02217709 - Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer Phase 2
Completed NCT03233555 - Extended Cancer Education for Longer-Term Survivors in Primary Care for Patients With Stage I-II Breast or Prostate Cancer or Stage I-III Colorectal Cancer N/A
Completed NCT00103194 - Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer Phase 2
Completed NCT02250014 - The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer Phase 1
Active, not recruiting NCT01655836 - High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer Phase 1
Terminated NCT01340599 - Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery Phase 2
Active, not recruiting NCT01823562 - Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery Phase 1
Active, not recruiting NCT01923506 - Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery Phase 1
Completed NCT01433913 - Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery Phase 2
Completed NCT00589472 - Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer Phase 2
Active, not recruiting NCT02176902 - Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer N/A
Completed NCT01731912 - Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer N/A
Completed NCT01656304 - Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy Phase 2
Recruiting NCT03880422 - Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors N/A
Completed NCT02048150 - Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer Phase 1
Withdrawn NCT01859689 - Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer Phase 2
Withdrawn NCT01555632 - Atorvastatin Calcium in Preventing Metabolic Syndrome in Prostate Cancer Patients Receiving Androgen-Deprivation Therapy N/A
Completed NCT00956163 - Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer Phase 0
Completed NCT01023061 - Abiraterone Acetate, Prednisone, and Leuprolide Acetate or Goserelin Before and During Radiation Therapy in Treating Patients With Localized or Locally Advanced Prostate Cancer Phase 2
Terminated NCT00058214 - Perifosine in Treating Patients With Recurrent Prostate Cancer Phase 2