Prospective Evaluation of Fluciclovine (18F) PET/CT in Patients with Prior Negative PSMA PET/CT

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

The REFINE study is evaluating whether a fluciclovine (18F) PET/CT scan can detect recurrent prostate cancer in patients whose previous PSMA PET/CT was negative or inconclusive.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is male and aged \>18 years old.

• Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of hormone sensitive PCa, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant therapy, c) RT and/or androgen deprivation therapy \[ADT\].

• An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: 1) Following RP with or without adjuvant therapy: PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL and within the total range of 0.2 and 2 ng/ml. PSA must be measured at least 6 weeks after RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng/mL and within the total range of 2 and 4 ng/ml

Locations
Other Locations
Germany
University Hospital Augsburg
NOT_YET_RECRUITING
Augsburg
TUM University Hospital
RECRUITING
Munich
Contact Information
Primary
Matthias Eiber, MD
matthias.eiber@tum.de
+49 89 4140 0
Time Frame
Start Date: 2025-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 94
Treatments
Prostate cancer patients with biochemical recurrence after negative/inconclusive PSMA PET/CT
This cohort comprises male patients with biochemically recurrent prostate cancer following definitive treatment-such as surgery or radiotherapy-who have previously undergone a PSMA PET/CT scan that was either negative or inconclusive. The primary intervention of interest is the fluciclovine (18F) PET/CT scan, which is performed as part of their routine clinical care to detect sites of recurrent disease.
Related Therapeutic Areas
Sponsors
Leads: Technical University of Munich

This content was sourced from clinicaltrials.gov