search
Back to results

Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate (POSH-MAP)

Primary Purpose

Prostate Adenocarcinoma

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Osanetant
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Kansas Cancer Center, Westwood CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot Trial: Osanetant 28 Days

Arm Description

Osanetant 200 mg orally, twice per day for 28 days.

Outcomes

Primary Outcome Measures

To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
Efficacy will be assessed using a composite outcome of median weekly hot flash frequency and severity at week 4 compared to baseline.

Secondary Outcome Measures

To evaluate the effect of Osanetant on follicle stimulating hormone for men with prostate cancer on ADT.
Levels of follicle stimulating hormone (FSH) will be measured at week 4 will be compared to baseline.
To evaluate the effect of Osanetant on luteinizing hormone for men with prostate cancer on ADT.
luteinizing hormone (LH) will be measured at week 4 will be compared to baseline.
To evaluate the effect of Osanetant on testosterone for men with prostate cancer on ADT.
testosterone will be measured at week 4 will be compared to baseline.
To evaluate the effect of Osanetant on estradiol for men with prostate cancer on ADT.
estradiol will be measured at week 4 will be compared to baseline. with prostate cancer on ADT
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
To evaluate the impact of Osanetant on global quality of life with Functional Assessment of Cancer Therapy-Prostate (FACT-P)
EuroQOL 5-dimension
To evaluate the impact of Osanetant on global quality of life with a visual analog scale from EuroQOL 5-dimension, 5-level (EQ-5D-5L). The EQ-5D-5L visual analog scale is 0-100 with higher numbers being better.
Patient Health Questionnaire-9 question (PHQ-9).
To evaluate the impact of Osanetant on depressive symptoms on Patient Health Questionnaire-9 question (PHQ-9).
General Anxiety Disorder-7 question (GAD-7)
To evaluate the impact of Osanetant on anxiety symptoms on General Anxiety Disorder-7 question (GAD-7).
Hot Flash Related Daily Interference Scale (HFRDIS).
To evaluate the impact of Osanetant on hot flash interference using the Hot Flash Related Daily Interference Scale (HFRDIS). The hot flash daily interference scale has a minimum of 0 and a max of 100, with higher scores indicating more interference (which is worse).

Full Information

First Posted
November 1, 2022
Last Updated
January 3, 2023
Sponsor
University of Kansas Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05647447
Brief Title
Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate
Acronym
POSH-MAP
Official Title
Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate (POSH-MAP)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single-arm pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot Trial: Osanetant 28 Days
Arm Type
Experimental
Arm Description
Osanetant 200 mg orally, twice per day for 28 days.
Intervention Type
Drug
Intervention Name(s)
Osanetant
Intervention Description
Osanetant 200 mg orally, twice per day
Primary Outcome Measure Information:
Title
To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
Description
Efficacy will be assessed using a composite outcome of median weekly hot flash frequency and severity at week 4 compared to baseline.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To evaluate the effect of Osanetant on follicle stimulating hormone for men with prostate cancer on ADT.
Description
Levels of follicle stimulating hormone (FSH) will be measured at week 4 will be compared to baseline.
Time Frame
28 days
Title
To evaluate the effect of Osanetant on luteinizing hormone for men with prostate cancer on ADT.
Description
luteinizing hormone (LH) will be measured at week 4 will be compared to baseline.
Time Frame
28 days
Title
To evaluate the effect of Osanetant on testosterone for men with prostate cancer on ADT.
Description
testosterone will be measured at week 4 will be compared to baseline.
Time Frame
28 days
Title
To evaluate the effect of Osanetant on estradiol for men with prostate cancer on ADT.
Description
estradiol will be measured at week 4 will be compared to baseline. with prostate cancer on ADT
Time Frame
28 days
Title
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
To evaluate the impact of Osanetant on global quality of life with Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time Frame
28 days
Title
EuroQOL 5-dimension
Description
To evaluate the impact of Osanetant on global quality of life with a visual analog scale from EuroQOL 5-dimension, 5-level (EQ-5D-5L). The EQ-5D-5L visual analog scale is 0-100 with higher numbers being better.
Time Frame
28 days
Title
Patient Health Questionnaire-9 question (PHQ-9).
Description
To evaluate the impact of Osanetant on depressive symptoms on Patient Health Questionnaire-9 question (PHQ-9).
Time Frame
28 days
Title
General Anxiety Disorder-7 question (GAD-7)
Description
To evaluate the impact of Osanetant on anxiety symptoms on General Anxiety Disorder-7 question (GAD-7).
Time Frame
28 days
Title
Hot Flash Related Daily Interference Scale (HFRDIS).
Description
To evaluate the impact of Osanetant on hot flash interference using the Hot Flash Related Daily Interference Scale (HFRDIS). The hot flash daily interference scale has a minimum of 0 and a max of 100, with higher scores indicating more interference (which is worse).
Time Frame
28 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KUCC Navigation
Phone
9135883671
Email
kucc_navigation@kumc.edu
Facility Information:
Facility Name
The University of Kansas Cancer Center, Westwood Campus
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Nurse Navigator
Phone
913-945-7552
Email
ctnursenav@kumc.edu

12. IPD Sharing Statement

Learn more about this trial

Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate

We'll reach out to this number within 24 hrs