Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 28, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 28, 2014
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 July 28, 2014