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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247312
First Posted: November 1, 2005
Last Update Posted: November 17, 2015
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.
Information provided by (Responsible Party):
Gregory Merrick, M.D., Schiffler Cancer Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 Gregory Merrick, M.D., 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. ]
    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 ]
    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. ]
    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. ]
    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. ]
    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 ]
    Post implant quality of life evaluations will be forwarded to Dr. G. Merrick as appropriate.


Enrollment: 319
Study Start Date: October 2005
Study Completion Date: November 2015
Primary Completion Date: November 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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): NCT00247312


Locations
United States, Washington
Radiation Oncology 174 Department of Veterans Affairs
Seattle, Washington, United States, 98108-1597
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
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
First Submitted: October 28, 2005
First Posted: November 1, 2005
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Gregory Merrick, M.D., Schiffler Cancer Center:
Prostate cancer
brachytherapy
palladium 103
I-125

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