Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

Status unconfirmed · Phase 4

Conditions studied: Prostate Neoplasms

In brief

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.

Key facts

Study ID: NCT01581749
Run by: Albert DeNittis
People needed: 50
Starts: 2011-10-01
Expected to finish: 2022-12-01
Last updated by the study team: 2016-03-23

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

Lankenau Medical Center, Radiation Oncology — Wynnewood, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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