Health TrialsbyHealthPanel

PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence

ConditionProstate Cancer (Post Prostatectomy)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorAdventHealth

About this trial

Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.

The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy.

An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5

Disqualifiers

Patients who are planned to have an x-ray contrast agent or other PET radiotracer & less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan.

Patients currently receiving Androgen Deprivation Therapy (ADT).

Trial design

Design model

Single group

Treatments tested in this trial

  • 18F-rhPSMA-7.3 (Posluma)

    Drug

    PET Scan using Posluma for detection of early recurrence of prostate cancer.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Open Label Main ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

Cancer Detection Rate

Patients who undergo at least one rhPSMA-7.3 (18F) PET-scan will be analyzed for the primary endpoint. The malignant lesion detectability rate will be summarized using percentage and 95% confidence interval estimates overall and for those who underwent a single scan or both scans. The diagnostic evaluation aims to identify individuals who are most likely to have an isolated local relapse, as they have the most significant potential for achieving long-term disease control through additional local therapy.

Time frame
24 months

Secondary outcomes

1

Correlation with biopsy

In those patients who undergo biopsy of a lesion, correlation with pathology report diagnosis will be reviewed.

Time frame
24 months
2

Correlation with other imaging modalities

In those patients who undergo other imaging modalities to confirm the results of the rhPSMA-7.3 (18F) PET-scan, correlation with other imaging modalities will be reviewed.

Time frame
24 months
3

Response to therapy

In those patients who undergo cancer directed therapy with radiation alone or with androgen deprivation therapy, the follow-up PSA test values after therapy will be reported.

Time frame
24 months
4

Adverse Events

Safety and toxicity data will be collected to evaluate any patient reported adverse effects. Safety Follow-up Call Within 24 hours of each Injection/Scan

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth

Lead sponsor

Blue Earth Diagnostics

Collaborator

Source ClinicalTrials.gov
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