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Trial Title:
Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
NCT ID:
NCT01581749
Condition:
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
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
"TrueBeam" stereotactic body radiosurgery
Description:
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this
study.
Arm group label:
36.25Gy to prostate in 5 fractions
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- histologically proven prostate adenocarcinoma within 1 year of enrollment
- Low 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
Gender:
Male
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lankenau Medical Center, Radiation Oncology
Address:
City:
Wynnewood
Zip:
19096
Country:
United States
Status:
Recruiting
Start date:
October 2011
Completion date:
December 2022
Lead sponsor:
Agency:
Albert DeNittis
Agency class:
Other
Source:
Main Line Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01581749
