A Phase 2 interventional study of Biospecimen Collection and Computed Tomography in Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8 and Stage III Prostate Cancer AJCC v8, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
Among 19 studies testing relugolix in Prostatic Neoplasms — 8 open to participants now, 12 under way, 1 of them phase 3. relugolix · Prostatic Neoplasms.
Among the 19 studies testing relugolix in Prostatic Neoplasms, this one is the 18th largest by planned enrollment, is one of 3 that started in 2025, is one of 12 in phase 2, reaches primary completion later than 7 of the 11 other live ones, and was the 17th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
Browse Prostatic Neoplasms studies →8 of the 19 studies testing relugolix in Prostatic Neoplasms are open now, in 1 country. Recruiting first, the newest first:
Baptist Health South Florida · Sites in United States
University of Utah · Sites in United States
Emory University · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
Yale University · Sites in United States
By country, each count listing its studies:
relugolix: first FDA approval 2020 (ORGOVYX), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 30 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 72 across the 19 interventional studies. Of the 7 that completed or were terminated, 6 (86%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 19 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
71 studies in Prostatic Neoplasms by Mayo Clinic: 19 open now, 24 under way, 2 of them phase 3. Of 43 finished, 12 (28%) have results posted.
Among the 71 studies in Prostatic Neoplasms by Mayo Clinic, this one is the 36th largest by planned enrollment of the 54 interventional ones that give a count, is one of 6 that started in 2025, is one of 18 in phase 2, reaches primary completion later than 17 of the 23 other live ones, and was the 66th registered.
Mayo Clinic’s Prostatic Neoplasms studies by the year they started, since 1997.
1 of the studies testing relugolix in Prostatic Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05765500Dana-Farber Cancer InstituteRecoverPC: Relugolix vs GnRH Agonist in Quality of Life | 2027-07-01 |
Among the 19 studies testing relugolix in Prostatic Neoplasms, from their registry updates:
Among Mayo Clinic’s 71 in Prostatic Neoplasms:
This tab as a report to print or save as PDF → With an account.
This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET/CT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET/CT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET/CT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET/CT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.
PRIMARY OBJECTIVE:
I. Comparison of maximum standard uptake value (SUVmax) and SUVmean values of the dominate primary prostate lesion between pre and post androgen deprivation therapy (ADT) imaging using flotufolastat F-18 gallium (POSLUMA [flotufolastat F 18]) PET/CT.
SECONDARY OBJECTIVES:
I. Evaluate and compare the lymph node sensitivity between pre and post ADT imaging using POSLUMA (flotufolastat F 18) PET/CT.
II. Comparison of lymph node prostate-specific membrane antigen (PSMA) avidity between pre and post ADT imaging using POSLUMA (flotufolastat F 18) PET/CT.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix orally (PO) once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 5. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
ARM B: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 10. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
ARM C: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-15 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 15. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
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.
Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of ORGOVYX (relugolix) for the time period specified:
Those with female partners of may be enrolled if they are:
Exclusion Criteria:
Any of the following prior therapies:
Uncontrolled intercurrent illness including, but not limited to:
Other active ≤ 1 year prior to registration
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 5. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Flotufolastat F-18 Gallium · Procedure: Laparoscopic Radical Prostatectomy with Robotics · Procedure: Pelvic Lymphadenectomy · Procedure: Positron Emission Tomography · Drug: Relugolix
Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 10. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Flotufolastat F-18 Gallium · Procedure: Laparoscopic Radical Prostatectomy with Robotics · Procedure: Pelvic Lymphadenectomy · Procedure: Positron Emission Tomography · Drug: Relugolix
Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-15 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 15. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Flotufolastat F-18 Gallium · Procedure: Laparoscopic Radical Prostatectomy with Robotics · Procedure: Pelvic Lymphadenectomy · Procedure: Positron Emission Tomography · Drug: Relugolix
Undergo collection of blood samples
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Given flotufolastat F 18
Also known as: (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3, Fluorine F 18 Radiohybrid PSMA-7.3, Fluorine F 18 rhPSMA-7.3, Fluorine-18 rhPSMA-7.3, Posluma, rhPSMA-7.3 (18F)
Undergo robotic assisted radical prostatectomy
Also known as: RARP, Robot-assisted Radical Prostatectomy
Undergo pelvic lymph node dissection
Also known as: Excision Pelvic Lymph Nodes, Pelvic Lymph Node Dissection
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Given PO
Also known as: N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385, TAK-385, TAK385
Maximum standard uptake value (SUVmax) for pre and post androgen deprivation therapy (ADT) prostate-specific antigen (PSMA) positron emission tomography (PET)
Will be compared in all patients (pooled across randomization groups). We will explore differences between 5, 10 and 15 days since ADT initiation as hypothesis-generating, but the study will not be powered to detect differences between these groups.
Time frame: Day 0 up to day 15
Mean standard uptake value (SUVmean) for pre and post ADT PSMA PET
Will be compared in all patients (pooled across randomization groups). We will explore differences between 5, 10 and 15 days since ADT initiation as hypothesis-generating, but the study will not be powered to detect differences between these groups
Time frame: Day 0 up to day 15
Lymph node sensitivity of the pre and post ADT PSMA PET with surgical pathology as standard of truth
Accuracy of imaging results (pre/post) for identifying either pelvic nodal or distant metastatic disease will be evaluated versus pathology result (standard of care). The reference standard regarding the presence of pelvic nodal or distant metastases will be determined by histopathologic findings.
Time frame: Day 0 up to day 15
Lymph node PSMA avidity between pre and post ADT PSMA using flotufolastat F 18 PET/computed tomography (CT)
Accuracy of imaging results (pre/post) for identifying either pelvic nodal or distant metastatic disease will be evaluated versus pathology result (standard of care).
Time frame: Day 0 up to day 15
Incidence of adverse events (AEs)
Assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.The maximum grade for each type of AE will be recorded for each patient.
Time frame: Up to 90 days following 2nd PSMA PET/CT (end of treatment)
Started Aug 2025 (actual). Primary completion is estimated for Jan 2029, 40 months after the start.
Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's planned 40 months is below that.
Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Relugolix