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Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
Conditions
Prostate Neoplasms
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
low risk prostate cancer, intermediate risk prostate cancer, stereotactic radiosurgery
Study Type
Interventional
Study Phase
Phase 4
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: "TrueBeam" stereotactic body radiosurgery
Type: Radiation
Overall Status
Recruiting
Summary
The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.
Detailed Description
The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. Examination and studies may be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.
At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. Examination and studies may be done at outside facility.
A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Male
Criteria: Inclusion Criteria:
- histologically proven prostate adenocarcinoma within 1 year of enrollment
- Low risk: Gleason
- Intermediate risk:Gleason 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0
- ECOG Performance Status 0-1
- No prior prostate radiation or other definitive therapy
Exclusion Criteria:
- implanted hardware or other material that would prohibit treatment planning or delivery
- chemotherapy for a malignancy within the previous 5 years
- history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years
- hormone ablation for 2 months prior to treatment or during treatment
- histologically proven prostate adenocarcinoma within 1 year of enrollment
- Low risk: Gleason
- Intermediate risk:Gleason
- ECOG Performance Status 0-1
- No prior prostate radiation or other definitive therapy
Exclusion Criteria:
- implanted hardware or other material that would prohibit treatment planning or delivery
- chemotherapy for a malignancy within the previous 5 years
- history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years
- hormone ablation for 2 months prior to treatment or during treatment
Location
Lankenau Medical Center, Radiation Oncology
Wynnewood, Pennsylvania, United States
Status: Recruiting
Start Date
October 2011
Completion Date
December 2022
Sponsors
Albert DeNittis
Source
Main Line Health
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page