Prostate AdenocarcinomaEarly Phase 1POSH-MAPNCT05647447
Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate
A Early Phase 1 study testing Osanetant in people with Prostate Adenocarcinoma, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
To evaluate the preliminary efficacy of in reducing the frequency and severity of hot flashes in men on androgen deprivation therapy (ADT). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Osanetant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 5 Oct 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
About this study
Official title: Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate (POSH-MAP)
To evaluate the preliminary efficacy of in reducing the frequency and severity of hot flashes in men on androgen deprivation therapy (ADT).
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Osanetant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsanetantDrug
Osanetant 200 mg orally, twice per day
| Study group | Role | What they receive |
|---|---|---|
| Pilot Trial: Osanetant 28 Days | Experimental | Osanetant 200 mg orally, twice per day for 28 days. Receives: Drug: Osanetant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (9)
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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
Measured: 28 days
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)
Measured: 28 days
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.
Measured: 28 days
Patient Health Questionnaire-9 question (PHQ-9).
To evaluate the impact of Osanetant on depressive symptoms on Patient Health Questionnaire-9 question (PHQ-9).
Measured: 28 days
General Anxiety Disorder-7 question (GAD-7)
To evaluate the impact of Osanetant on anxiety symptoms on General Anxiety Disorder-7 question (GAD-7).
Measured: 28 days
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).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start3 Jan 2023
- Primary completion22 Sep 2023
- Study completion5 Oct 2023
Why it stopped: Development of the drug program has been discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pilot
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647447
- Sponsor's protocol ID
- STUDY00148766
- Acronym
- POSH-MAP
- Status last verified
- Feb 2024
- First submitted
- 1 Nov 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate (POSH-MAP)
- ClinicalTrials.gov ID
- NCT05647447
- Acronym / sponsor ID
- POSH-MAP / STUDY00148766
- Conditions
- Prostate Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development of the drug program has been discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the preliminary efficacy of in reducing the frequency and severity of hot flashes in men on androgen deprivation therapy (ADT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot
| Arm | Type | Receives |
|---|---|---|
| Pilot Trial: Osanetant 28 Days | Experimental | Drug: OsanetantOsanetant 200 mg orally, twice per day for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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,
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsanetantOsanetant 200 mg orally, twice per day | Drug | Pilot Trial: Osanetant 28 Days |
Primary outcome
To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
Time frame: 28 days
Efficacy will be assessed using a composite outcome of median weekly hot flash frequency and severity at week 4 compared to baseline.
9 secondary outcomes
To evaluate the effect of Osanetant on follicle stimulating hormone for men with prostate cancer on ADT.
Time frame: 28 days
To evaluate the effect of Osanetant on luteinizing hormone for men with prostate cancer on ADT.
Time frame: 28 days
To evaluate the effect of Osanetant on testosterone for men with prostate cancer on ADT.
Time frame: 28 days
To evaluate the effect of Osanetant on estradiol for men with prostate cancer on ADT.
Time frame: 28 days
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: 28 days
EuroQOL 5-dimension
Time frame: 28 days
Patient Health Questionnaire-9 question (PHQ-9).
Time frame: 28 days
General Anxiety Disorder-7 question (GAD-7)
Time frame: 28 days
Hot Flash Related Daily Interference Scale (HFRDIS).
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Osanetant in people with Prostate Adenocarcinoma, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT). (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.