Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Internal Radiation Therapy With or Without External-Beam Radiation Therapy in Treating Patients With Localized Prostate Cancer

This study has been terminated.
(Slow accrual causing impracticality)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00714753
First received: July 11, 2008
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Radiation: brachytherapy
Radiation: hypofractionated radiation therapy
Radiation: image-guided radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Treatment tolerance (genitourinary [GU] or gastrointestinal [GI] adverse events) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Association between dose-volume limitations for organs at risk and rate and severity of GU or GI adverse events [ Designated as safety issue: Yes ]
  • Patient preference for a second treatment (a second high dose-rate brachytherapy session or an external beam radiotherapy session) [ Designated as safety issue: No ]
  • Changes in health-related quality of life scores [ Designated as safety issue: No ]
  • Freedom from biochemical and clinical failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Disease-specific survival [ Designated as safety issue: No ]
  • Time to local tumor progression [ Designated as safety issue: No ]
  • Distant failure [ Designated as safety issue: No ]
  • Freedom from salvage androgen suppression treatment [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: August 2008
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714753

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Thomas M. Pisansky, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Thomas M. Pisansky, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00714753     History of Changes
Other Study ID Numbers: CDR0000600446, P30CA015083, MC0652, 08-001451
Study First Received: July 11, 2008
Last Updated: May 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014