We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Internal Radiation Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573833
First Posted: December 14, 2007
Last Update Posted: October 20, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity [ Time Frame: At scheduled 3 month intervals for one year ]
    Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity

  • Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity [ Time Frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities) ]
    urinary and rectal toxicity-see the adverse event tables


Other Outcome Measures:
  • Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint [ Time Frame: week 12 reported ]
    Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)

  • Median International Prostate Symptom Total Score [ Time Frame: week 12 reported ]
    Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92).


Enrollment: 23
Study Start Date: November 2007
Study Completion Date: September 2014
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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
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:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00573833     History of Changes
Other Study ID Numbers: 07-120
MSKCC-07120
First Submitted: December 13, 2007
First Posted: December 14, 2007
Results First Submitted: December 21, 2015
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017

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