Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer

NCT01787331 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 125513NCI-2013-02375
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7; Stage III Prostate Adenocarcinoma AJCC v7

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Achieve a Greater Than or Equal to 50% Decline in Serum Prostate Specific Antigen (PSA)

  The number of patients with biochemically relapsed disease after prior definitive local therapy who achieve a ≥ 50% decline from baseline in serum PSA after 12 weeks of therapy with itraconazole, confirmed by repeat measurement at least 2 weeks later.

  At 12 weeks after start of treatment

Secondary Outcomes (8)

• Mean Percent Change in PSA Doubling Time

  Up to 12 weeks

• Median Time to PSA Progression

  Up to 2 years

• Median Time to Clinical Progression

  Up to 2 years

• Median Metastasis-free Survival

  Up to 2 years

• Percentage of Participants With Treatment-related, Adverse Changes in Vital Signs

  Up to 2 years

Study Arms (1)

Treatment (itraconazole)

EXPERIMENTAL

Patients receive twice/day 300mg itraconazole (oral)

Drug: Itraconazole; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Itraconazole DRUG

Given PO

Also known as: Lozanoc, Oriconazole, R 51,211, Sporanox

Treatment (itraconazole)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (itraconazole)

Pharmacological Study OTHER

Correlative studies

Treatment (itraconazole)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:
• 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
• Prior androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist and/or antagonist allowed for either (neo)adjuvant treatment with local therapy or for biochemical relapse
• Last effective dose of LHRH agonist/antagonist ?expired? \> 3 months prior to study entry; for example, a patient receiving LHRH agonist injection every 3 months would be eligible provided their last injection was \> 6 months prior to day 1 of protocol therapy; a patient receiving LHRH agonist injections every 4 months will be eligible provided last injection was \> 7 months prior to day 1 of protocol therapy
• Serum testosterone level:
• If no prior androgen deprivation therapy:
• A single measurement greater than 150 ng/dL within 3 months of day 1 of protocol therapy

You may not qualify if:

• 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
• Use of other medications that may potentially interact with itraconazole within 1 week of study entry
• Use of other investigational agents within 6 weeks of day 1 of protocol therapy
• Prior pathology consistent with small cell carcinoma or prostate cancer with predominantly neuroendocrine differentiation

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Mina Lee, Haemin Hong, Won Kim, Terence W. Friedlander, Lawrence Fong, Amy M. Lin, Eric Jay Small, Mallika Sachdev Dhawan, Xiao X. Wei, Tammy J. Rodvelt, Brigid Miralda, Charles J. Ryan, and Rahul Raj Aggarwal.A phase II study of itraconazole in biochemically recurrent prostate cancer. Journal of Clinical Oncology 2018 36:6_suppl, 362-362

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Limitations and Caveats

No evaluable data was collected from validated assay. Long term, metastatic disease status data was also not collected.

Results Point of Contact

• Title: Rahul Aggarwal, MD
• Organization: University of California, San Francisco

cancertrials@ucsf.edu

877-827-3222

Study Officials

• Rahul Aggarwal, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: October 29, 2013
• Primary Completion: May 30, 2017
• Study Completion: September 30, 2018
• Last Updated: February 5, 2020
• Results First Posted: October 23, 2018

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)