Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

Albert DeNittis

Status and phase

Unknown

Phase 4

Conditions

Prostate Neoplasms

Treatments

Radiation: "TrueBeam" stereotactic body radiosurgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01581749

R12-3104L

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Male

Ages

21+ years old

Volunteers

No Healthy Volunteers

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