Clinical trial · Interventional
FACBC for Recurrent Prostate Cancer
Transmolecular Imaging of Recurrent Prostate Carcinoma With Exploration of Genomic Markers Differences Between Local and Distant Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FACBC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FACBC
- description
- Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT detection of cancer recurrence.
- interventionNames
- Drug: FACBC
Primary outcomes (2)
- measure
- The Presence of Cancer Tissue Inside of the Prostate Bed
- timeFrame
- Up to 43 months
- description
- Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where: 1. = definitely benign 2. = probably benign 3. = equivocal 4. = probably malignant 5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be 18 years of age or older. 2. Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive non-prostatectomy therapy for localized disease. 3. In the case of cryotherapy, external beam radiation, or High-Intensity Focused Ultrasound (HiFU) the procedure will have occurred at least one year in the past. In the case of brachytherapy, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump." 4. Patient will have suspicion of recurrent prostate carcinoma as defined by: the Radiation Therapy Oncology Group (RTOG) - American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix criteria of nadir PSA +2, and absolute PSA ≥ 4.0 ng/ml.with any doubling time (DT) or with PSA 2.0-3.99 ng/ml with DT ≤10 months 5. Ability to lie still for PET scanning 6. Patients must be able to provide written informed consent. Exclusion Criteria: 1. Age less than 18. 2. Greater than T3 disease in past and/or treated with prostatectomy. 3. Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy.. 4. Does not meet above criteria of suspicious PSA elevation 5. Inability to lie still for PET scanning 6. Cannot provide written informed consent. 7. Bone scan findings characteristic for metastatic prostate carcinoma 8. Less than 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation). \-
References
Publications (1)
- RESULTAkin-Akintayo O, Tade F, Mittal P, Moreno C, Nieh PT, Rossi P, Patil D, Halkar R, Fei B, Master V, Jani AB, Kitajima H, Osunkoya AO, Ormenisan-Gherasim C, Goodman MM, Schuster DM. Prospective evaluation of fluciclovine (18F) PET-CT and MRI in detection of recurrent prostate cancer in non-prostatectomy patients. Eur J Radiol. 2018 May;102:1-8. doi: 10.1016/j.ejrad.2018.02.006. Epub 2018 Feb 24. PMID 29685521