Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

This study is currently recruiting participants.
Verified July 2013 by Main Line Health
Sponsor:
Information provided by (Responsible Party):
Albert DeNittis, Main Line Health
ClinicalTrials.gov Identifier:
NCT01581749
First received: April 18, 2012
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Prostate Neoplasms
Radiation: "TrueBeam" stereotactic body radiosurgery
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Main Line Health:

Primary Outcome Measures:
  • acute and late GI/GU toxicity rate following treatment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.


Secondary Outcome Measures:
  • a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    For the low-risk cohort, the study is powered to compare 5-year bDFS rates observed with TrueBeam STx to 5-year bDFS rates reported with dose-escalated external beam RT. In Beaumont's monotherapy HDR series treating LR patients, 5-yr ASTRO bDFS was 98%; in Demanes' series of 75% LR and 25% IR, this was 96%. Since TB delivers doses similar to HDR monotherapy, a conservative estimate of the success rate for TB is 97.5% for LR patients.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: "TrueBeam" stereotactic body radiosurgery
    36.25Gy to be delivered to the prostate in 5 fractions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 & 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581749

Contacts
Contact: Department of Radiation Oncology 484-476-3587

Locations
United States, Pennsylvania
Lankenau Medical Center, Radiation Oncology Recruiting
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Albert DeNittis
Investigators
Principal Investigator: Albert DeNittis, MD Lankenau Medical Center, Main Line Health
  More Information

Publications:
Responsible Party: Albert DeNittis, Chief, Radiation Oncology. Lankenau Medical Center, Main Line Health, Main Line Health
ClinicalTrials.gov Identifier: NCT01581749     History of Changes
Other Study ID Numbers: R12-3104L
Study First Received: April 18, 2012
Last Updated: July 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Main Line Health:
low risk prostate cancer
intermediate risk prostate cancer
stereotactic radiosurgery

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014