Hormone boost may sharpen prostate cancer scans
NCT ID NCT07025369
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a short course of hormone therapy (relugolix) can make PSMA PET/CT scans better at finding prostate cancer that has spread to lymph nodes. About 30 men with high-risk prostate cancer will get the hormone drug for 5, 10, or 15 days before their scan. The goal is to see if the treatment increases the cancer cells' brightness on the scan, helping doctors detect smaller areas of disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Histological confirmation of prostate adenocarcinoma * Diagnosis of high risk or very high risk prostate cancer per National Comprehensive Cancer Network (NCCN) Risk Stratification. \[Any of the following: grade group 4 or 5, prostate-specific antigen (PSA) greater than 20, radiographic cT3 on MRI\] * Testosterone greater than or equal to 300 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Hemoglobin ≥ 9.0 g/dL (obtained ≤ 120 days prior to registration/randomization) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 120 days prior to registration/randomization) * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 120 days prior to registration/randomization) * 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: * Use a condom during sex while being treated and for 30 days after the last dose of ORGOVYX (relugolix) * Do not make semen donations during treatment and for 30 days after the last dose of ORGOVYX (relugolix) * Those with female partners of childbearing potential may be enrolled if they are: * Documented to be surgically sterile (i.e., vasectomy); * Committed to practicing true abstinence during treatment and for 30 days after the last ORGOVYX (relugolix) dose; or * Committed to using an effective method of contraception with their partner during treatment and for 30 days following the last dose of ORGOVYX (relugolix) * Provide written informed consent Exclusion Criteria: * Any of the following prior therapies: * Chemotherapy ≤ 2 weeks prior to registration/randomization * Androgen deprivation therapy * Pelvic radiation * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Or psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy ≤ 1 year prior to registration * EXCEPTIONS: Non-melanotic skin cancer * NOTE: If there is a history of prior malignancy, they must not be receiving other active treatment for their cancer * History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * Use of P-glycoprotein inhibitors
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Arizona
RECRUITINGScottsdale, Arizona, 85259, United States
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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- Can 3D imaging make prostate radiation more precise and worth the cost?