A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET

NCT06859203 | Recruiting

• 1 other identifier: 2024-643-S-NP
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Biochemical Recurrence of Malignant Neoplasm of Prostate

Keywords

prostate cancer; biochemical recurrence; PET; PSMA; fluciclovine; BCR; prostate

Outcome Measures

Primary Outcomes (1)

• Patient-level detection rate

  The patient-level detection rate of fluciclovine (18F) PET/CT in patients with a prior negative or inconclusive PSMA-ligand PET/CT

  From enrollment to the end of observation at 1 year

Secondary Outcomes (4)

• Region level detection rate

  From enrollment to the end of observation at 1 year

• Detection rate stratified by PSA level

  From enrollment to the end of observation at 1 year

• Intended management change

  From enrollment to the end of observation at 1 year

• Interreader agreement

  From enrollment to the end of observation at 1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosis of BCR and negative or inconclusive PSMA-ligand PET of previous radically treated PCa, aged ≥18 years old, eligible for fluciclovine PET/CT.

You may qualify if:

• 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

You may not qualify if:

• Patients with any medical condition or circumstance (including receiving an investigational product) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
• Current or recent androgen deprivation therapy (ADT) within 3 months prior to the start of the study, which includes surgical orchidectomy, continuous or intermittent LHRH agonist/antagonist, and first-/second-generation anti androgen alone or combined with LHRH agonist/antagonist.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (2)

University Hospital Augsburg

Augsburg, Bavaria, 86156, Germany

NOT YET RECRUITING

TUM University Hospital

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Matthias Eiber, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Eiber, MD

CONTACT

+49 89 4140 0; matthias.eiber@tum.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

DE (2)