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Completed

NCT Number: NCT01352598

Stereotactic Body Radiotherapy for Prostate Cancer

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

About this study

This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age >= 18 years
  • Zubrod performance status of 0-3
  • T1-3 N0 M0 adenocarcinoma of the prostate
  • Prostate volume ≤ 100 cc
  • Signed study-specific consent form

Exclusion criteria

  • Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
  • Prostate volume > 100 cc
  • Nodal involvement
  • Metastatic disease
  • Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
  • History of scleroderma
  • Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Treatment and study plan

stereotactic body radiotherapy

Radiation

Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.

Primary outcomes

  1. Biochemical Control Rate

    Time frame: one year

    Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.

Secondary outcomes

  1. Late Toxicity Rate

    Time frame: one year

    Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.

Sponsors and collaborators

Lead sponsor

Mercy Research

Other

Registry information

Official study title

Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
May 12, 2011
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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