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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714753
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : June 6, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Radiation: brachytherapy Radiation: hypofractionated radiation therapy Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
Study Start Date : August 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Treatment tolerance (genitourinary [GU] or gastrointestinal [GI] adverse events)

Secondary Outcome Measures :
  1. Association between dose-volume limitations for organs at risk and rate and severity of GU or GI adverse events
  2. Patient preference for a second treatment (a second high dose-rate brachytherapy session or an external beam radiotherapy session)
  3. Changes in health-related quality of life scores
  4. Freedom from biochemical and clinical failure
  5. Overall survival
  6. Disease-free survival
  7. Disease-specific survival
  8. Time to local tumor progression
  9. Distant failure
  10. Freedom from salvage androgen suppression treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00714753

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Thomas M. Pisansky, MD Mayo Clinic

Responsible Party: Mayo Clinic Identifier: NCT00714753     History of Changes
Other Study ID Numbers: CDR0000600446
P30CA015083 ( U.S. NIH Grant/Contract )
MC0652 ( Other Identifier: Mayo Clinic Cancer Center )
08-001451 ( Other Identifier: Mayo Clinic IRB )
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: February 2016

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

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