Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
OBJECTIVES:
Primary
- Evaluate the tolerability of 2 radiotherapeutic regimens (high dose-rate brachytherapy
[HDR] with or without image-guided intensity-modulated hypofractionated external beam
radiotherapy [EBRT]), as measured by the Common Terminology Criteria for Adverse Events
(CTCAE v3.0), in patients with localized prostate cancer.
Secondary
- Identify any associations between dose-volume parameters for organs at risk and the
rate and severity of genitourinary or gastrointestinal adverse events.
- Evaluate patient preference with regard to selection of a second treatment (a second
HDR brachytherapy session or an EBRT session).
- Evaluate patient-reported health-related quality of life (HRQOL) as measured by
validated HRQOL instruments for 5 years.
- Describe the probability of freedom from biochemical and clinical failure.
- Describe the probability of freedom from salvage androgen suppression.
OUTLINE: Patients undergo high dose-rate (HDR) brachytherapy (2 fractions ≥ 5 hours apart).
Beginning 2-4 weeks after completion of the first HDR brachytherapy session, patients
undergo either a second session of HDR brachytherapy (2 fractions ≥ 5 hours apart) OR
image-guided intensity-modulated hypofractionated external beam radiotherapy once daily 5
days a week for 3 weeks.
Quality of life is assessed at baseline, prior to the second treatment session, at 1 and 6
months after completion of treatment, every 6 months for 3 years, and then annually for 2
years.
After completion of study treatment, patients are followed at 1 and 6 months, every 6 months
for 3 years, and then annually for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate, meeting one of the following
criteria:
- Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA < 10 ng/mL)
- Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA < 20 ng/mL OR
T1-T2a, Gleason score 7, and PSA < 10 ng/mL)
- No known nodal (N0 or NX) or distant (M0 or MX) metastases
- No pubic arch interference, as defined by either of the following:
- Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension
< 4.3 cm
- No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation
at A10°I beam's eye view
- Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal
ultrasound
- American Urological Association voiding symptom index ≤ 12
- Peak uroflow rate (Q_max) ≥ 12 cc/second
- Post-void ultrasound bladder residual volume ≤ 100 cc
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Life expectancy ≥ 5 years
- WBC > 2,000/μL
- Platelet count > 100,000/μL
- PT < 1.5 times upper limit of normal
- No diabetes mellitus associated with vascular ulcers or wound-healing problems
- No blood dyscrasias
- No inflammatory bowel disease
- No connective tissue disorder
- No other prior or concurrent invasive malignancy (except nonmelanoma skin cancer) or
lymphomatous or hematological malignancy (except chronic lymphocytic
leukemia/lymphoma) unless patient has been continually disease-free for ≥ 5 years
- No medical or psychiatric condition that would preclude giving informed consent or
complying with study treatment
- Able to undergo anesthesia
PRIOR CONCURRENT THERAPY:
- No prior transurethral resection of the prostate
- No prior prostatic cryoablation or high-intensity focused ultrasound
- No prior prostatectomy
- No prior prostatic enucleation
- No prior pelvic external beam radiotherapy
- No prior radionuclide prostate brachytherapy
- No prior hemi- or total hip arthroplasty
- Neoadjuvant androgen suppression therapy allowed provided it was initiated 2-6 months
prior to study entry and its total duration is ≤ 6 months
- No concurrent anticoagulation therapy, including heparin or coumadin
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Treatment tolerance (genitourinary [GU] or gastrointestinal [GI] adverse events)
Safety Issue:
Yes
Principal Investigator
Thomas M. Pisansky, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000600446
NCT ID:
NCT00714753
Start Date:
August 2008
Completion Date:
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage II prostate cancer
- adenocarcinoma of the prostate
- Prostatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
