A Phase 2 interventional study of Clomiphene Citrate 25mg in Prostate Cancer, sponsored by University of Nebraska. Not yet recruiting at 1 site in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 83 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Clomiphene Citrate 25mg
Oral clomiphene citrate, 25 mg, once daily for 6 months, then tested for persistence of response (eugonadal testosterone) after a 1-month washout period
To evaluate the proportion of participants with eugonadal serum testosterone (≥ 300 ng/dL).
Time frame: 6 Months
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Clomiphene