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Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer


Phase 4
21 Years
N/A
Open (Enrolling)
Male
Prostate Neoplasms

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Trial Information

Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer


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.


Inclusion Criteria:



- histologically proven prostate adenocarcinoma within 1 year of enrollment

- Low risk: Gleason
- Intermediate risk:Gleason 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

acute and late GI/GU toxicity rate following treatment

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Albert DeNittis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lankenau Medical Center, Main Line Health

Authority:

United States: Institutional Review Board

Study ID:

R12-3104L

NCT ID:

NCT01581749

Start Date:

October 2011

Completion Date:

December 2022

Related Keywords:

  • Prostate Neoplasms
  • low risk prostate cancer
  • intermediate risk prostate cancer
  • stereotactic radiosurgery
  • Neoplasms
  • Prostatic Neoplasms

Name

Location
Lankenau Medical Center, Radiation Oncology Wynnewood, Pennsylvania  19096