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

NCT ID: NCT06617481

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2027-10-10

Brief Summary

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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.

Detailed Description

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This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.

Conditions

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Prostate Cancer (Post Prostatectomy)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Open Label Main Arm

Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)

Group Type OTHER

18F-rhPSMA-7.3 (Posluma)

Intervention Type DRUG

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

Interventions

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18F-rhPSMA-7.3 (Posluma)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Blue Earth Diagnostics

INDUSTRY

Sponsor Role collaborator

AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AdventHealth

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AdventHealth AdventHealth Oncology Research

Role: CONTACT

407-303-2090

Facility Contacts

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AdventHealth AdventHealth Oncology Research

Role: primary

407-303-2090

Guru Sonpavde, MD, MD

Role: backup

Other Identifiers

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IRBNet # 2067493

Identifier Type: OTHER

Identifier Source: secondary_id

AdventH

Identifier Type: -

Identifier Source: org_study_id

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