Prostate CancerPhase 2NCT07882862
HRT-PC Trial: Hormone Recovery After Treatment for Prostate Cancer Trial. An Open-label Phase II Study of Clomiphene Citrate in Patients With Persistent Hypogonadism After ADT for Treatment of Localized Prostate Cancer
A Phase 2 study testing Clomiphene Citrate 25mg in people with Prostate Cancer, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this phase II trial is to assess the clinical utility of clomiphene citrate for the augmentation of testosterone in prostate cancer survivors who complete androgen deprivation therapy (ADT), including the efficacy and tolerability of clomiphene, patient-reported quality of life outcomes, metabolic… Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Clomiphene Citrate 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2027to 31 Jan 2037
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of adenocarcinoma of the prostate
- No evidence of metastatic disease
- Prior definitive local therapy with radiation
- Prior definitive continuous ADT 4-17 months in duration (treatment may include abiraterone).
- Available serum testosterone measurement. Testosterone < 300 ng/dL is required for inclusion in Cohort A; testosterone ≥300 ng/dL is required for inclusion in Cohort R.
- PSA <0.1
- ECOG performance status < 3
- Prior pre-treatment staging (bone and soft tissue imaging) that ruled out metastatic disease
Who cannot join
- Known hypogonadism prior to initiation of ADT
- Prior prostatectomy
- Known endocrine or liver dysfunction
- Polycythemia
- Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Known intracranial tumor
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- Psychiatric illness/social situations or geographical condition that would limit compliance with study requirements
- Use of clomiphene citrate, testosterone, or other hormone replacement therapy
- Recent (within the last 3 months) venous thromboembolism
- Severe lower urinary tract symptoms
- Use of inhibitors or inducers of CYP2D6
- Symptoms suggestive of recurrent or metastatic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University if Nebraska Medical Center
Omaha, Nebraska, 68198
IIT Office, 402-559-5669, IITOffice@unmc.edu
Benjamin Teply, MD
About this study
The purpose of this phase II trial is to assess the clinical utility of clomiphene citrate for the augmentation of testosterone in prostate cancer survivors who complete androgen deprivation therapy (ADT), including the efficacy and tolerability of clomiphene, patient-reported quality of life outcomes, metabolic effects, biomarkers of response, and the oncologic safety of increasing testosterone.
Up to 83 eligible participants who have completed radiation and ADT for non-metastatic prostate cancer will participate in this study. Participants are assigned to one of two cohorts: Cohort A is comprised intermediate-risk survivors who underwent short-course ADT (4-17 mo.) and are hypogonadal ≥6 months after ending ADT, and Cohort R is comprised of survivors who recovered to eugonadal levels of testosterone (≥ 300 ng/dL) within 6 months after ending ADT.
Read more
Participants will be evaluated for clinical findings, toxicities, laboratory abnormalities (CBC, CMP, Lipid panel, Hgb A1C), changes to the hypothalamic-pituitary-gonadal axis (E2, LH, FSH, TT) [dependent on Cohort], biochemical recurrence (PSA), and quality of life (FACT-P, FACT-Fatigue, qADAM).
Cohort R is an observational natural-recovery control group and will not be treated. Cohort A will be treated with oral clomiphene citrate, 25 mg, once daily for 6 months, then tested for persistence of response (eugonadal testosterone) after a 1-month washout period.
After completing study assessments, participants will transition to standard survivorship follow-up. Thereafter, long-term health outcomes will be reviewed to determine the rates of biochemical recurrence and metastasis after 5 years.
- Conditions
- Prostate Cancer
- Being tested
- Clomiphene Citrate 25mg
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene Citrate 25mgDrug
Oral clomiphene citrate, 25 mg, once daily for 6 months, then tested for persistence of response (eugonadal testosterone) after a 1-month washout period
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - oral clomiphene citrate, 25 mg, once daily for 6 months | Experimental | Not described Receives: Drug: Clomiphene Citrate 25mg |
| Cohort R is an observational natural-recovery control group and will not be treated | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the proportion of participants with eugonadal serum testosterone (≥ 300 ng/dL).
Measured: 6 Months
Secondary outcomes (1)
To evaluate the change in total testosterone as indicated by change from serum testosterone at baseline through end of study (EOS).
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start31 Jan 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Teply, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882862
- Sponsor's protocol ID
- HRTPC
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRT-PC Trial: Hormone Recovery After Treatment for Prostate Cancer Trial. An Open-label Phase II Study of Clomiphene Citrate in Patients With Persistent Hypogonadism After ADT for Treatment of Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07882862
- Acronym / sponsor ID
- HRTPC
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 31 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Jan 2037 (estimated)
- First posted
- 20 Oct 2026 (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.
The purpose of this phase II trial is to assess the clinical utility of clomiphene citrate for the augmentation of testosterone in prostate cancer survivors who complete androgen deprivation therapy (ADT), including the efficacy and tolerability of clomiphene, patient-reported quality of life outcomes, metabolic effects, biomarkers of response, and the oncologic safety of increasing testosterone.
Up to 83 eligible participants who have completed radiation and ADT for non-metastatic prostate cancer will participate in this study. Participants are assigned to one of two cohorts: Cohort A is comprised intermediate-risk survivors who underwent short-course ADT (4-17 mo.) and are hypogonadal ≥6 months after ending ADT, and Cohort R is comprised of survivors who recovered to eugonadal levels of testosterone (≥ 300 ng/dL) within 6 months after ending ADT.
Participants will be evaluated for clinical findings, toxicities, laboratory abnormalities (CBC, CMP, Lipid panel, Hgb A1C), changes to the hypothalamic-pituitary-gonadal axis (E2, LH, FSH, TT) [dependent on Cohort], biochemical recurrence (PSA), and quality of life (FACT-P, FACT-Fatigue, qADAM).
Cohort R is an observational natural-recovery control group and will not be treated. Cohort A will be treated with oral clomiphene citrate, 25 mg, once daily for 6 months, then tested for persistence of response (eugonadal testosterone) after a 1-month washout period.
After completing study assessments, participants will transition to standard survivorship follow-up. Thereafter, long-term health outcomes will be reviewed to determine the rates of biochemical recurrence and metastasis after 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - oral clomiphene citrate, 25 mg, once daily for 6 months | Experimental | Drug: Clomiphene Citrate 25mg |
| Cohort R is an observational natural-recovery control group and will not be treated | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic diagnosis of adenocarcinoma of the prostate
- No evidence of metastatic disease
- Prior definitive local therapy with radiation
- Prior definitive continuous ADT 4-17 months in duration (treatment may include abiraterone).
- Available serum testosterone measurement. Testosterone < 300 ng/dL is required for inclusion in Cohort A; testosterone ≥300 ng/dL is required for inclusion in Cohort R.
Key exclusion criteria (12 listed)
- Known hypogonadism prior to initiation of ADT
- Prior prostatectomy
- Known endocrine or liver dysfunction
- Polycythemia
- Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
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 |
|---|---|---|
| Clomiphene Citrate 25mgOral clomiphene citrate, 25 mg, once daily for 6 months, then tested for persistence of response (eugonadal testosterone) after a 1-month washout period | Drug | Cohort A - oral clomiphene citrate, 25 mg, once daily for 6 months |
Primary outcome
To evaluate the proportion of participants with eugonadal serum testosterone (≥ 300 ng/dL).
Time frame: 6 Months
1 secondary outcome
To evaluate the change in total testosterone as indicated by change from serum testosterone at baseline through end of study (EOS).
Time frame: 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Benjamin Teply, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clomiphene Citrate 25mg in people with Prostate Cancer, run by University of Nebraska 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IIT Office (402-559-4596, iitoffice@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the proportion of participants with eugonadal serum testosterone (≥ 300 ng/dL). (time frame: 6 Months). 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 20 Oct 2026.