Internal Radiation Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00573833
First received: December 13, 2007
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.


Condition Intervention
Prostate Cancer
Other: questionnaire administration
Procedure: quality-of-life assessment
Radiation: brachytherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Feasibility [ Time Frame: At scheduled 3 month intervals for one year ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTC and the International Prostate Symptom Score Index [ Time Frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities) ] [ Designated as safety issue: Yes ]
  • Quality of life as measured by the MSKCC Prostate Quality of Life questionnaire [ Time Frame: At scheduled 3 month intervals for one year ] [ Designated as safety issue: No ]
  • Sexual function as measured by the International Index of Erectile Function (IIEF) [ Time Frame: At scheduled 3 month intervals for one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2007
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
Other: questionnaire administration Procedure: quality-of-life assessment Radiation: brachytherapy

Detailed Description:

OBJECTIVES:

Primary

  • To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
  • To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity < 10% and grade 3 rectal toxicity < 10%).

Secondary

  • To achieve adequate dosimetric coverage of the prostate comparable to current standards.
  • To assess the effect of treatment on sexual function.

OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.

Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.

After completion of study treatment, patients are followed every 3 months for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:

    • PSA 10-20 ng/mL
    • Gleason score ≥ 7
    • Stage ≥ T2b AND < T3
  • Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
  • Prostate size < 60 cc by MRI or CT imaging
  • International Prostate Symptom Score Index ≤ 15

Exclusion criteria:

  • Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)

    • Suspected extracapsular disease will not be considered an exclusion criteria
  • PSA > 20 ng/mL
  • Presence of distant metastases

PATIENT CHARACTERISTICS:

  • WBC ≥ 3,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 mg/dL
  • Liver function tests ≤ 1.5 times normal
  • INR ≤ 2.5
  • Able to complete quality of life questionnaires
  • Able to give informed consent
  • No active perineal infections
  • No history of urethral stricture
  • No prior history of pelvic malignancy
  • No prior history of lymphoma disease, ulcerative colitis, or anal fissures
  • No contraindications to general anesthesia
  • No pacemaker

PRIOR CONCURRENT THERAPY:

  • No prior transurethral resection of the prostate
  • No prior pelvic radiotherapy
  • No prior treatment for prostate cancer except for hormone therapy
  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: NCT00573833

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Josh Yamada, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Michael J. Zelefsky, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Sherri M. Donat, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Marco Zaider, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00573833     History of Changes
Other Study ID Numbers: 07-120, MSKCC-07120
Study First Received: December 13, 2007
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer

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

ClinicalTrials.gov processed this record on July 20, 2014