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Tests treatment safety and results for Prostate Cancer
Official title Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
ClinicalTrials.gov ID: NCT07455903
What this study is testing
What is Leuprolide?
Leuprolide is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for prostate cancer.
Also referred to as Lupron, Eligard.
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
- The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).
- Phase 2: a mid-size study of how well it works
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
- Signed informed consent must be obtained prior to participation in the study.
- Males aged ≥18 years.
- ECOG performance status ≤ 1
- Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy
- Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.
You likely can't join if
- Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.
- Unable to receive androgen deprivation therapy.
- Prostate cancer with significant neuroendocrine or other rare variant pathology
- Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT
- Renal impairment (glomerular filtration rate \<30 mL/min)
- History of prior radiation therapy for prostate cancer
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the study.
- Males aged ≥18 years.
- ECOG performance status ≤ 1
- Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy
- Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.
- cT3-cT4
- International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10)
- PSA \>20 ng/mL
- Clinically negative lymph nodes as established by PSMA PET/CT imaging. Patients who are node positive by PSMA PET/CT (e.g., N1), but whose nodes do not meet traditional size criteria for positivity (e.g., they measure ≥...
- Patient is willing to use barrier-method of contraception along with another effective contraceptive method if engaged in sexual activity with a pregnant person or individual of childbearing potential (until 1 week...
- Clinical laboratory values during screening:
- Hemoglobin ≥ 10.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L
- Platelets ≥ 100 × 10⁹/L
- Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.
- Unable to receive androgen deprivation therapy.
- Prostate cancer with significant neuroendocrine or other rare variant pathology
- Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT
- Renal impairment (glomerular filtration rate \<30 mL/min)
- History of prior radiation therapy for prostate cancer
- Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant ventricular arrhythmias, or...
- Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or untreated HIV infection.
- Other malignancies other than prostate cancer in the past 5 years a. Cured basal cell or squamous cell skin cancers can be enrolled.
- Severe or uncontrolled concurrent infections are not eligible.
- Treated with concomitant cytotoxic cancer therapy for any other primary site.
- Patients who are unable to complete the study requirements of 2nd PSMA imaging or surgery for the primary endpoints.
- Any condition that, in the opinion of the investigator, would preclude participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, 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 Miami, Florida, 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.