Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
NCT ID: NCT01581749
Last Updated: 2016-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2011-10-31
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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36.25Gy to prostate in 5 fractions
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.
"TrueBeam" stereotactic body radiosurgery
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.
Interventions
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"TrueBeam" stereotactic body radiosurgery
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.
Eligibility Criteria
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Inclusion Criteria
* Low risk: Gleason \<or=6 \& PSA \<or=10 \& Clinical Stage T1b-T2a,Nx or N0, Mx or M0
* Intermediate risk:Gleason \<or=6 \& PSA\<or=10 \& Clinical Stage T2b OR Gleason=7 \& PSA\<or=10 \& Clinical Stage T1b-T2b OR Gleason \<or=6 \& PSA \> 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
* 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
21 Years
MALE
No
Sponsors
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Albert DeNittis
OTHER
Responsible Party
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Albert DeNittis
Chief, Radiation Oncology. Lankenau Medical Center, Main Line Health
Principal Investigators
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Albert DeNittis, MD
Role: PRINCIPAL_INVESTIGATOR
Lankenau Medical Center, Main Line Health
Locations
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Lankenau Medical Center, Radiation Oncology
Wynnewood, Pennsylvania, United States
Countries
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Central Contacts
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Department of Radiation Oncology
Role: CONTACT
References
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King CR, Lehmann J, Adler JR, Hai J. CyberKnife radiotherapy for localized prostate cancer: rationale and technical feasibility. Technol Cancer Res Treat. 2003 Feb;2(1):25-30. doi: 10.1177/153303460300200104.
Other Identifiers
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R12-3104L
Identifier Type: -
Identifier Source: org_study_id
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