NCT01581749

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

6.2 years

First QC Date

April 18, 2012

Last Update Submit

March 22, 2016

Conditions

Prostate Neoplasms

Keywords

low risk prostate cancerintermediate risk prostate cancerstereotactic radiosurgery

Outcome Measures

Primary Outcomes (1)

  • acute and late GI/GU toxicity rate following treatment

    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.

    5 years

Secondary Outcomes (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

    5 years

Study Arms (1)

36.25Gy to prostate in 5 fractions

OTHER

36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.

Radiation: "TrueBeam" stereotactic body radiosurgery

Interventions

"TrueBeam" stereotactic body radiosurgeryRADIATION

36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.

36.25Gy to prostate in 5 fractions

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lankenau Medical Center, Radiation Oncology

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 12625751BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Albert DeNittis, MD

    Lankenau Medical Center, Main Line Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Department of Radiation Oncology

CONTACT

484-476-3587

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Radiation Oncology. Lankenau Medical Center, Main Line Health

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 20, 2012

Study Start

October 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2022

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

US(1)