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New treatment option for Prostate Adenocarcinoma
Official title Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial
ClinicalTrials.gov ID: NCT07025369
What this study is testing
What is Relugolix?
Relugolix is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate adenocarcinoma.
Also referred to 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.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Testosterone greater than or equal to 300
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
You likely can't join if
- 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...
- Uncontrolled intercurrent illness including, but not limited to:
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.