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RecruitingEarly Phase 1

An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial

ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: PET scans, CT scans, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up."
  • "A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body."
  • "Combining a PET scan with a CT scan can help make the image easier to interpret."
  • "PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination."
  • "After completion of study intervention, patients are followed up at 14 days and then every 3 months for 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a PET/CT scan using a radioactive tracer called rhPSMA-7.3 (POSLUMA) can find prostate cancer that may have returned after treatment. It is for men with rising PSA, a blood marker for prostate cancer, whose recent scan using a different tracer found no clear signs of cancer.

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. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men who had prostate adenocarcinoma, a type of prostate cancer, treated in the prostate area, such as with surgery, with or without later radiation.
  • PSA has risen after treatment to at least 0.1 ng/mL.
  • PSA is below 0.5 ng/mL, measured within 90 days of joining.
  • A PSMA PET scan within 90 days of joining showed no cancer or unclear results. It must have used an FDA-approved tracer other than POSLUMA.
  • Testosterone, a male hormone, is above 50 ng/dL, measured within 90 days of joining.
  • Must be able to understand and willing to sign the study consent form. Required consent and privacy forms must be completed before study procedures.
  • Other illnesses and cancers are allowed.

Who can't join

  • Most recent PSA is outside the study's required range: at least 0.1 ng/mL but below 0.5 ng/mL.
  • Prostate cancer that has not spread but has rising PSA despite testosterone below 50 ng/dL.
  • Use of hormone-related medicines called 5-alpha reductase inhibitors, androgen deprivation therapy, or androgen receptor blockers within 3 months of joining. These medicines may be started right after the POSLUMA scan if the doctor decides.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 representative prior to any study-related procedures * 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 Exclusion Criteria: * 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 POSLUMA PET PSMA scan)

Study sites (1)

IL