Stage II Prostate Adenocarcinoma AJCC v7 Clinical Trial
Official title:
Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed treatment regimens at 2 years post-treatment. SECONDARY OBJECTIVES: I. Estimate the change in health related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire. II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific antigen (PSA) at 5 years. V. Determine the rate of local failure by biopsy of the prostate when objective tests, prostate-specific antigen (PSA), magnetic resonance imaging (MRI), digital rectal exam (DRE), suggest relapse. OUTLINE: Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks. After completion of study treatment, patients are followed up every 6-12 months for 24 months and then annually until month 60. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01787331 -
Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer
|
Phase 2 | |
| Completed |
NCT02326805 -
PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance
|
Phase 2 | |
| Completed |
NCT02830165 -
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
|
N/A | |
| Active, not recruiting |
NCT03541850 -
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
|
Phase 2 |