Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

Last updated: March 22, 2016
Sponsor: Albert DeNittis
Overall Status: Active - Recruiting

Phase

4

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT01581749
R12-3104L
  • Ages > 21
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • histologically proven prostate adenocarcinoma within 1 year of enrollment

  • 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 & ClinicalStage T1b- T2b, Nx or NO, Mx or M0

  • ECOG Performance Status 0-1

  • No prior prostate radiation or other definitive therapy

Exclusion

Exclusion Criteria:

  • implanted hardware or other material that would prohibit treatment planning ordelivery

  • chemotherapy for a malignancy within the previous 5 years

  • history of an invasive malignancy (other than this prostate cancer,or basal orsquamous skin cancers) within prior 5 years

  • hormone ablation for 2 months prior to treatment or during treatment

Study Design

Total Participants: 50
Study Start date:
October 01, 2011
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Lankenau Medical Center, Radiation Oncology

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

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