A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative o… (NCT06859203) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET
Germany94 participantsStarted 2025-03
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
What they're measuring
1
Patient-level detection rate
Timeframe: From enrollment to the end of observation at 1 year