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Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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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 ClinicRochester, Minnesota  55905