Recruiting

Truebeam

Sponsor:

Albert DeNittis

Code:

NCT01581749

Conditions

Prostate Neoplasms

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Interventions

"TrueBeam" stereotactic body radiosurgery

Study Details

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.

Conditions

Prostate Neoplasms

Study ID

NCT01581749

Start date

Oct, 2011

Status verified date

Mar, 2016

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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.

Interventions

"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 measure

  • acute and late GI/GU toxicity rate following treatment [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Department of Radiation Oncology

484-476-3587

Locations

Lankenau Medical Center, Radiation Oncology

Recruiting

Wynnewood, Pennsylvania, United States, 19096

More Information

Sponsor

Albert DeNittis

Last update posted

Mar 23, 2016

Last verified

Mar, 2016

Keywords

  • low risk prostate cancer
  • intermediate risk prostate cancer
  • stereotactic radiosurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Albert DeNittis on 2016-03-23.