Clinical trial NCT05647447: Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate
Official title: Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate (POSH-MAP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Prostate Adenocarcinoma
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm pilot
Primary purpose: TREATMENT

Brief summary: To evaluate the preliminary efficacy of in reducing the frequency and severity of hot flashes in men on androgen deprivation therapy (ADT).


Eligibility criteria: Inclusion Criteria:

* 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 prostate cancer (PCa)
* Undergoing active treatment with ADT within ≥ 30 days prior to randomization
* Using either an gonadotropin releasing hormone (GNRH) agonist with a planned duration covering the 8 weeks of the study or are status post bilateral orchiectomy,
* Have a castrate level of testosterone (≤ 50 ng/dL) at enrollment
* Have moderate-to-severe hot flashes defined as

  * Seven (7) or more hot flashes per day
  * Total hot flash severity (HFS: total number of hot flashes for 1 week multiplied by the average severity/week) ≥ 100
* Adequate organ function, defined as follows: Result Date

  * Leukocytes \> 1.5K/UL
  * Absolute Neutrophil Count (ANC) \>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
  * 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 ≤ 1.5 x ULN
* Women of child-bearing potential and men with partners of childbearing 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 and for 30 days following completion of therapy.

Exclusion Criteria:

* Concurrent invasive malignancy or invasive malignancy within 2 years except for chronic lymphocytic leukemia/small lymphocytic lymphoma on surveillance, suspected or proven clinical stage 1 (cT1) renal cell carcinoma on active surveillance, or the following malignancies treated with curative intent via surgical resection: carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, low-grade non-muscle-invasive urothelial carcinoma, non-melanoma skin cancer.
* Simultaneously enrolled in any therapeutic clinical trial
* Current or anticipating use of other pharmacologic anti-neoplastic (including hormonal), or investigational agents while participating in this study. Concurrent treatment with radiotherapy is permitted.
* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
* 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.
* Participants 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.

Primary outcomes:
measure: To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
timeFrame: 28 days
Secondary outcomes:
measure: To evaluate the effect of Osanetant on follicle stimulating hormone for men with prostate cancer on ADT.
timeFrame: 28 days
measure: To evaluate the effect of Osanetant on luteinizing hormone for men with prostate cancer on ADT.
timeFrame: 28 days
measure: To evaluate the effect of Osanetant on testosterone for men with prostate cancer on ADT.
timeFrame: 28 days
measure: To evaluate the effect of Osanetant on estradiol for men with prostate cancer on ADT.
timeFrame: 28 days
measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: 28 days
measure: EuroQOL 5-dimension
timeFrame: 28 days
measure: Patient Health Questionnaire-9 question (PHQ-9).
timeFrame: 28 days
measure: General Anxiety Disorder-7 question (GAD-7)
timeFrame: 28 days
measure: Hot Flash Related Daily Interference Scale (HFRDIS).
timeFrame: 28 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
Study officials:
References: