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Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Schiffler Cancer Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Schiffler Cancer Center
ClinicalTrials.gov Identifier:
NCT00247312
First received: October 28, 2005
Last updated: September 19, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to determine the most appropriate radiation implant dose for palladium-103 monotherapy. Radiation dose is related to potential cure. From previously published studies, it appears that the prescribed radiation dose can be reduced by 14-20% without any difference in potential cure (in this study, the dose is being decreased 10%). Although most patients tolerate brachytherapy well, complications to appear to be related to radiation exposure to normal structures (i.e. urethra, rectum and proximal penis). By reducing the prescribed dose, it is conceivable that fewer patients will experience side effects and complications.


Condition Intervention Phase
Prostatic Neoplasm
 Radiation: Pd-103
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schiffler Cancer Center:

Primary Outcome Measures:
  • PSA determinations will be obtained 3 months following implantation and then every 6 months.
  • Androgen deprivation therapy will not be initiated unless the PSA exceeds 10 ng/mL or distant metastases are detected.

Secondary Outcome Measures:
  • Following brachytherapy, I-PSS will be obtained on months 1, 3, 6, 12, 18, 24, 36, 48, 60.
  • Following brachytherapy, R-FAS will be obtained on months 12, 36 and 60.
  • Following brachytherapy, IIEF will be obtained on months 12, 36 and 60.
  • Post implant quality of life evaluations will be forwarded to Dr. G. Merrick as appropriate.

Estimated Enrollment: 600
Study Start Date: October 2005
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
Active Comparator: 125Gy prescription dose Pd-103 Radiation: Pd-103
Active Comparator: 110 Gy prescription dose Pd-103 Radiation: Pd-103

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Low risk patients: Gleason score less than or equal to 6, PSA less than or equal to 10 ng/mL and clinical stage T1b-T2b (2002 AJCC.
  • An enzymatic prostatic acid phosphatase must be obtained prior to implantation.
  • No pelvic external beam radiation therapy for either prostate cancer or other malignancies.
  • Androgen deprivation therapy less than 4 month duration for size reduction is allowable.
  • No surgical staging for prostate cancer.
  • A minimum of 5 year life expectancy.
  • No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.

Exclusion Criteria:

  • Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247312

Contacts
Contact: Gregory S. Merrick, MD 304-243-3490 gmerrick@urologicresearchinstitute.org

Locations
United States, Washington
Radiation Oncology 174 Department of Veterans Affairs Recruiting
Seattle, Washington, United States, 98108-1597
Contact: Kent E Wallner, MD     206-768-5356     kent.wallner@med.va.gov    
United States, West Virginia
Schiffler Cancer Center Recruiting
Wheeling, West Virginia, United States, 26003
Contact: Gregory S. Merrick, MD     304-243-3490     gmerrick@urologicresearchinstitute.org    
Contact: Robin Stipetich, RN, OCN     304-243-3490        
Principal Investigator: Gregory S. Merrick, MD            
Sponsors and Collaborators
Schiffler Cancer Center
Investigators
Principal Investigator: Gregory S. Merrick, MD Schiffler Cancer Center, Wheeling, WV
Study Chair: Kent E. Wallner, MD Department of Veterans Affairs, Seattle, WA
  More Information

Publications:

Responsible Party: Gregory S. Merrick, MD, Schiffler Cancer Center
ClinicalTrials.gov Identifier: NCT00247312     History of Changes
Other Study ID Numbers: 05-8-3
Study First Received: October 28, 2005
Last Updated: September 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Schiffler Cancer Center:
Prostate cancer
brachytherapy
palladium 103
I-125

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

ClinicalTrials.gov processed this record on May 16, 2013