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COMPLETEDPHASE2

Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer

Hedgehog Inhibition as a Non-Castrating Approach to Hormone Sensitive Prostate Cancer: A Phase II Study of Itraconazole in Biochemical Relapse

NCT01787331•University of California, San Francisco

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVES: I. To determine whether the proportion of patients who achieve a \>= 50% decline in serum prostate-specific antigen (PSA) after 12 weeks of protocol therapy with itraconazole dosed at 300 mg orally (PO) twice daily (BID) is superior to a historical control based upon the observed PSA response proportion in prior studies of non-castrating systemic therapy in men with biochemically relapsed hormone sensitive prostate cancer. SECONDARY OBJECTIVES: I. To determine the median time to PSA progression from the start of protocol therapy with itraconazole among men with biochemically relapsed prostate cancer. II. To determine the median time to clinical progression measured from the start of protocol therapy with itraconazole among men with biochemically relapsed prostate cancer. III. To determine the median metastasis-free survival measured from the start of protocol therapy in patients treated with itraconazole for biochemically relapsed prostate cancer. IV. To determine the mean percent change from baseline after 12 weeks of protocol therapy compared with pre-treatment in PSA doubling time. V. To characterize the safety profile of itraconazole in the biochemically relapsed hormone sensitive prostate cancer population, as graded by Common Toxicity Criteria (CTCAE) version 4.03. All adverse events will be tabulated by grade according to the worst grade experienced. VI. To determine the mean steady-state itraconazole and hydroxy-itraconazole serum levels after 4 weeks of therapy with itraconazole.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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/pelvis (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) within 6 weeks of day 1 of protocol therapy
+22 more criteria

Exclusion Criteria

•Castrate-resistant disease, as evidenced by either:
•* Rising PSA on 2 consecutive measurements at least 2 weeks apart with concurrent documented serum testosterone \< 50 ng/dL at the time of PSA measurement, or
•* Rising PSA on 2 consecutive measurements at least 2 weeks apart measured within 3 months after last LHRH agonist/antagonist injection
•Prior bilateral orchiectomy
•Congestive heart failure of New York Heart Association (NYHA) class III or higher severity at study entry
•History of chronic active hepatitis
•Grade 2 or higher peripheral neuropathy at the time of study entry
•Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) or antiandrogen (i.e. flutamide, bicalutamide) within 6 weeks of day 1 of protocol therapy
•Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher within 6 weeks of day 1 of protocol therapy
•Use of medications or herbal supplements which are known to potentially lower serum PSA within 6 weeks of day 1 of protocol therapy
+3 more criteria

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

October 29, 2013

Primary Completion Date

May 30, 2017

Completion Date

September 30, 2018

Last Updated

February 5, 2020

Enrollment

ACTUAL participants

Conditions

Prostate AdenocarcinomaRecurrent Prostate CarcinomaStage I Prostate Adenocarcinoma AJCC v7Stage II Prostate Adenocarcinoma AJCC v7Stage III Prostate Adenocarcinoma AJCC v7

Interventions

Itraconazole

DRUG

Laboratory Biomarker Analysis

OTHER

Pharmacological Study

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer

Feasibility of Patient-Centered Home Care (PCHC) to Reduce Disparities in High-Risk Black Men (BM) With Prostate Cancer (CaP)

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma