Clinical Trials

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Prostate Cancer Clinical Trials

Hormone Therapy for Localized Prostate Cancer Post Radiation/Prostatectomy (97-3730-A/C 06)
Intermittent Hormone Therapy in Men with Localized Prostate Cancer who Have Biochemical Relapse After External Beam Irradiation or Radical Prostatectomy
Status Conditions Phase Study ID
Closed Genitourinary Cancer; Prostate Cancer; Solid Tumors Phase II 97-3730-A/C 06
NCT00223665
Summary

Sometimes blood levels of prostatic specific antigen (PSA) will rise in men who have had prostate surgery or received radiation therapy for localized prostate cancer. A low value for the PSA is more desirable as is may indicate no tumor growth. Giving the hormone therapy intermittently (in cycles of treatment and off treatment periods) appears to delay the change of prostate cancer to a type of prostate cancer that resists hormone therapy. If it does, the prostate cancer will be treatable for a longer period of time, as well as improve the quality of life. Mental functioning is monitored during therapy to see if this treatment has any impact on memory or ability to carry out tasks. In addition, extra tubes of blood are obtained to test for Amyloid-B protein (AB protein) whose presence may be associated with problem solving decline.


Investigator
Tia Higano, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate
  • Clinical stage A2, B, C, D1
  • Age: older than 21 years old
  • Performance status of 0 or 1
  • Pretreatment serum testosterone, normal range (or no clinical evidence of testosterone deficiency).
  • If less than 30 months since completion of radiation therapy, biopsy of prostate suggested within 6 months of study entry.
  • If more than or equal to 30 months since completion of radiation therapy, biopsy of prostate suggested within 1 year.
  • Written informed consent.
Last Updated
March 13, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.