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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Schiffler Cancer Center
Sponsor:
Information provided by (Responsible Party):
Gregory Merrick, M.D., Schiffler Cancer Center
ClinicalTrials.gov Identifier:
NCT00247312
First received: October 28, 2005
Last updated: May 29, 2013
Last verified: May 2013
  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:


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. [ Time Frame: every 6 months after inital PSA done at 3 months. ] [ Designated as safety issue: No ]
    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. [ Time Frame: depends on outcome ] [ Designated as safety issue: No ]
    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. [ Time Frame: months 1, 3, 6, 12, 18, 24, 36, 48, 60. ] [ Designated as safety issue: No ]
    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. [ Time Frame: months 12, 36 and 60. ] [ Designated as safety issue: No ]
    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. [ Time Frame: months 12, 36 and 60. ] [ Designated as safety issue: No ]
    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. [ Time Frame: as needed ] [ Designated as safety issue: No ]
    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: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 125Gy prescription dose Pd-103
125Gy prescription dose Pd-103
Radiation: Pd-103
Active Comparator: 110 Gy prescription dose Pd-103
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
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: 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 Merrick, M.D., Medical Director, 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: May 29, 2013
Health Authority: United States: Institutional Review Board

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

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 October 29, 2014