Clinical trial NCT01581749: Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
Official title: Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prostate Neoplasms
Keywords: low risk prostate cancer
intermediate risk prostate cancer
stereotactic radiosurgery
Lead sponsor: Main Line Health
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 50
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: acute and late GI/GU toxicity rate following treatment
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
Other outcomes:
Locations:
city: Wynnewood
country: United States
facility: Lankenau Medical Center, Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: Lankenau Medical Center, Main Line Health
name: Albert DeNittis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.