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Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01581749
Recruitment Status : Recruiting
First Posted : April 20, 2012
Last Update Posted : March 23, 2016
Information provided by (Responsible Party):
Albert DeNittis, Main Line Health

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Neoplasms Radiation: "TrueBeam" stereotactic body radiosurgery Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer
Study Start Date : October 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
Radiation: "TrueBeam" stereotactic body radiosurgery
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.

Primary Outcome Measures :
  1. acute and late GI/GU toxicity rate following treatment [ Time Frame: 5 years ]
    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 :
  1. 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 ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01581749

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Contact: Department of Radiation Oncology 484-476-3587

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United States, Pennsylvania
Lankenau Medical Center, Radiation Oncology Recruiting
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Albert DeNittis
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Principal Investigator: Albert DeNittis, MD Lankenau Medical Center, Main Line Health
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Responsible Party: Albert DeNittis, Chief, Radiation Oncology. Lankenau Medical Center, Main Line Health, Main Line Health Identifier: NCT01581749    
Other Study ID Numbers: R12-3104L
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Keywords provided by Albert DeNittis, Main Line Health:
low risk prostate cancer
intermediate risk prostate cancer
stereotactic radiosurgery
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases