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New treatment option for Biochemically Recurrent Prostate Carcinoma
Official title An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial
ClinicalTrials.gov ID: NCT06813898
What this study is testing
What is Flotufolastat F-18 Gallium?
Flotufolastat F-18 Gallium is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biochemically recurrent prostate carcinoma.
Also referred to as (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3.
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 evaluates an imaging technique (rhPSMA-7.3 positron emission tomography [PET]/computed tomography [CT]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, men only
You may be able to join if
- Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary...
- Men must have biochemical recurrence (defined as PSA \>= 0.1ng/ml) after therapy
- PSA \< 0.5ng/ml (within 90 days of enrollment)
- Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved...
- Non-castrate testosterone (testosterone [T] \> 50ng/dL) within 90 days of study entry
You likely can't join if
- Most recent PSA not between 0.1ng/ml and 0.5ng/ml
- Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \< 50ng/dl)
- Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men...
See the full eligibility criteria
- Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy [i.e. salvage radiation])
- Men must have biochemical recurrence (defined as PSA \>= 0.1ng/ml) after therapy
- PSA \< 0.5ng/ml (within 90 days of enrollment)
- Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer
- Non-castrate testosterone (testosterone [T] \> 50ng/dL) within 90 days of study entry
- Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized...
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
- Concurrent diseases and malignancies are permitted
- Most recent PSA not between 0.1ng/ml and 0.5ng/ml
- Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \< 50ng/dl)
- Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, 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.