Pilot of Osanetant to Reduce Testosterone in Men With Adenocarcinoma of the Prostate

NCT05607342 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: STUDY00148767
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of Osanetant on the testosterone levels.

  We will test the ability of Osanetant to suppress testosterone production. A single arm pilot study of Osanetant at 200mg twice daily will be performed. Testosterone levels at baseline will be compared to levels at day 2, 3, 7 ,14, and 28 days of therapy. The overall effect of Osanetant on testosterone levels and the proportion of men achieving castrate levels of testosterone (\<50ng/ml) will be assessed. Additionally, the reversibility of this effect will be assessed by evaluating the testosterone levels at 6-8 weeks posttreatment.

  28 days

Secondary Outcomes (4)

• To evaluate the effect of Osanetant on LH levels.

  28 days

• To evaluate the effect of Osanetant on FSH levels.

  28 days

• To evaluate the effect of Osanetant on estradiol levels

  28 days

• To evaluate the effect of Osanetant on PSA levels.

  28 days

Study Arms (1)

Pilot Trial: Osanetant 28 Days

EXPERIMENTAL

Pilot Trial: A single dose level (200mg twice daily, oral) will be provided for men with prostate cancer undergoing curative intent surgery. Men will undergo serum testing at baseline, days 2, 3, 7, 14, and 28 as well as 6 weeks post-treatment in order to evaluate efficacy. All men enrolled will be subject to the same study procedures and assessments, regardless of completion of the study protocol, and analysis will occur via intent-to-treat principles.

Drug: Osanetant

Interventions

Osanetant DRUG

To evaluate the effect of Osanetant on the testosterone levels.

Pilot Trial: Osanetant 28 Days

Eligibility Criteria

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

You may qualify if:

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• Males ≥ 18 years
• Histologic diagnosis of adenocarcinoma of the prostate (PCa)
• Planned radical prostatectomy within the study period
• Testosterone \>150ng/ml
• Adequate organ function, defined as follows: Result Date
• Leukocytes \>1.5K/UL
• Absolute Neutrophil Count \>1.5K/UL
• NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.
• Platelets \>100K/UL
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
• Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
• Men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation. Men of child-bearing potential must not father a child or donate sperm while receiving investigational treatment. Following treatment (standard of care prostatectomy) there is no further child-bearing potential.

You may not qualify if:

• Current or recent (within 6 months) use of testosterone/estrogen modulating agents (leuprolide, degarelix, bicalutamide, enzalutamide, apalutamide, darolutamide, abiraterone, systemic ketoconazole, tamoxifen, etc)
• Current use of CYP3A4 inhibitors
• Subjects using the following medications within 2 weeks prior to first dosing (or within 5 times the half-life of that medication, whichever is longer) will be excluded from the study:
• Inhibitors of CYP3A4 (including but not limited to macrolide antibiotics, HIV protease inhibitor, azole antifungal drugs, cyclosporine, calcium channel inhibitor, cimetidine)
• Inducers of CYP3A4 (including but not limited to rifampicin, carbamazepine, efavirenz, bosentan, modafinil, St. John's Wort), Medications with narrow therapeutic index that are metabolized CYP3A4 and/or CYP2D6 are not allowed from screening until up to 5 half-lives after last dose of Osanetant is administered.
• Cognitive impairment (defined as the presence of diagnosed dementia)
• Impaired renal function: Cr \>1.8
• Medical history of osteoporosis
• Current systemic corticosteroid, long-term opioid, spironolactone, or eplerenone use
• Has a known allergic reaction to any excipient contained in the study drug formulation
• Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
• Active COVID-19 infection
• Any history of underlying liver disorder, including hepatitis (see below)
• Any evidence of acute or chronic hepatitis B or C on screening testing
• Elevation of any or all liver enzymes (ALT, AST, total bilirubin) above the upper limit of normal (ULN) at baseline testing prior to enrollment

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

Location

MeSH Terms

Interventions

SR 142801

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, pilot clinical trial

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: January 3, 2023
• Primary Completion: September 22, 2023
• Study Completion: November 6, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

US (1)