Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer (NCT01787331) | Clinical Trial Compass
CompletedPhase 2
Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer
United States21 participantsStarted 2013-10-29
Plain-language summary
This phase II trial studies how well itraconazole works in treating patients with biochemically relapsed prostate cancer. Itraconazole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic confirmation of adenocarcinoma of the prostate
* Biochemically relapsed disease with a rising PSA on at least two successive measurements at least two weeks apart after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy (RT) with curative intent; if the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA will be required to documents progression
* Prior primary or salvage radiation or not a candidate for salvage radiation due to patient preference or clinical assessment based upon disease characteristics and/or patient co-morbidities
* Minimum PSA:
* If no prior androgen deprivation therapy (ADT) for biochemical relapse:
* 1.0 ng/mL if prior radical prostatectomy with or without adjuvant/salvage radiation therapy, confirmed by repeat measurement at least 2 weeks later, or
* Nadir + 2 ng/mL if prior RT alone without prior radical prostatectomy, confirmed by repeat measurement at least 2 weeks later
* If prior ADT for biochemical relapse:
* 4.0 ng/mL or \> 2 ng/mL above nadir on prior cycle of ADT, whichever is higher, confirmed by repeat measurement at least 2 weeks later
* No evidence of metastatic disease on imaging by whole body bone scan (technetium-99 or sodium fluoride \[Na-F\] positron emission tomography \[PET\] bone scan) and cross-sectional imaging of the abdomen/pe…
What they're measuring
1
Number of Patients Who Achieve a Greater Than or Equal to 50% Decline in Serum Prostate Specific Antigen (PSA)