Prostate AdenocarcinomaEarly Phase 1PORT-MAPNCT05607342
Pilot of Osanetant to Reduce Testosterone 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 effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy. 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
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 6 Nov 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 adenocarcinoma of the prostate (PCa)
- Planned radical prostatectomy within the study period
- Testosterone >150ng/ml
- Adequate organ function, defined as follows: Result Date
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- 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.
Who cannot join
- 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)
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- 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
- A family history of hepatitis or currently living with a person who has been given a diagnosis of hepatitis
- A history of or currently working as a sex worker
- A history of or currently using intravenous (IV) drugs
- A self-reported history of alcoholic dependency or abuse
- A history of or current diagnosis of cardiovascular disease including heart failure, coronary artery disease, uncontrolled hypertension, uncontrolled diabetes; arrhythmias (or history of), or clinically relevant ECG abnormalities at baseline
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 Testosterone in Men With Adenocarcinoma of the Prostate (PORT-MAP)
To evaluate the effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy.
Read the detailed description
Primary:
To evaluate the effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy.
Secondary:
- To evaluate the effect Osanetant on pituitary hormones (LH/FSH) and estrogen within 28 days of therapy.
- To evaluate the effect of Osanetant on PSA levels after 28 days (approximately 4 weeks) of therapy.
- 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
To evaluate the effect of Osanetant on the testosterone levels.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Osanetant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (4)
To evaluate the effect of Osanetant on LH levels.
Levels of luteinizing hormone (LH) will be measured at baseline and days 2, 3, 7 ,14, and 28. These will be compared at each time point in order to assess the impact of NK3RA on these hormonal parameters.
Measured: 28 days
To evaluate the effect of Osanetant on FSH levels.
Levels of follicle stimulating hormone (FSH) will be measured at baseline and days 2, 3, 7 ,14, and 28. These will be compared at each time point in order to assess the impact of NK3RA on these hormonal parameters.
Measured: 28 days
To evaluate the effect of Osanetant on estradiol levels
Levels of estradiol will be measured at baseline and days 2, 3, 7 ,14, and 28. These will be compared at each time point in order to assess the impact of NK3RA on these hormonal parameters.
Measured: 28 days
To evaluate the effect of Osanetant on PSA levels.
PSA will be compared at baseline and 28 days of therapy in order to evaluate the end biochemical efficacy of Osanetant on men with prostate cancer undergoing curative intent therapy.
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 posted7 Nov 2022
- Study start3 Jan 2023
- Primary completion22 Sep 2023
- Study completion6 Nov 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 clinical trial
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT05607342
- Sponsor's protocol ID
- STUDY00148767
- Acronym
- PORT-MAP
- Status last verified
- Feb 2024
- First submitted
- 31 Oct 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 Testosterone in Men With Adenocarcinoma of the Prostate (PORT-MAP)
- ClinicalTrials.gov ID
- NCT05607342
- Acronym / sponsor ID
- PORT-MAP / STUDY00148767
- Conditions
- Prostate Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of the drug program has been discontinued
- Enrolment
- 1 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
- 6 Nov 2023 (actual)
- First posted
- 7 Nov 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 effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy.
Detailed description
Primary:
To evaluate the effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy.
Secondary:
- To evaluate the effect Osanetant on pituitary hormones (LH/FSH) and estrogen within 28 days of therapy.
- To evaluate the effect of Osanetant on PSA levels after 28 days (approximately 4 weeks) of therapy.
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 clinical trial
| Arm | Type | Receives |
|---|---|---|
| Pilot Trial: Osanetant 28 Days | Experimental | Drug: OsanetantPilot 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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 adenocarcinoma of the prostate (PCa)
- Planned radical prostatectomy within the study period
- Testosterone >150ng/ml
Key exclusion criteria (20 listed)
- 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:
- Cognitive impairment (defined as the presence of diagnosed dementia)
- Impaired renal function: Cr >1.8
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 |
|---|---|---|
| OsanetantTo evaluate the effect of Osanetant on the testosterone levels. | Drug | Pilot Trial: Osanetant 28 Days |
Primary outcome
To evaluate the effect of Osanetant on the testosterone levels.
Time frame: 28 days
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.
4 secondary outcomes
To evaluate the effect of Osanetant on LH levels.
Time frame: 28 days
To evaluate the effect of Osanetant on FSH levels.
Time frame: 28 days
To evaluate the effect of Osanetant on estradiol levels
Time frame: 28 days
To evaluate the effect of Osanetant on PSA levels.
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Development of the drug program has been discontinued). Results are not available in the source record.
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 15 inclusion and 20 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: stopped early, 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 stopped early (reason given: Development of the drug program has been discontinued). Results are not available in the source record.
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 effect of Osanetant on the testosterone levels. (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.