Clinical trial · Interventional
18F-FCH PET/MRI to Assess Tumor Response in Castration Resistant Prostate Cancer
Assessment of CRPC Response Through Comprehensive Characterization Using Novel Biomarkers (PET CRPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess response to treatment in men with castration resistant prostate cancer (CRPC). It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack thereof) earlier in the treatment period, providing a better guide for treating men with CRPC.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [F-18]-FCH | Other | — | UNRESOLVED |
| MRI scan | Radiation | — | UNRESOLVED |
| PET scan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Docetaxel
- description
- Patients who will be receiving Docetaxel as cancer treatment will be assigned to Arm 1. All patients in this cohort will have a \[F-18\]-FCH PET scan with full body MRI scan
- interventionNames
- Other: [F-18]-FCH
- Radiation: PET scan
- Radiation: MRI scan
- type
- OTHER
- label
- Abiraterone
- description
- Patients who will be receiving Abiraterone as cancer treatment will be assigned to Arm 2. All patients in this cohort will have a \[F-18\]-FCH PET scan with full body MRI scan.
- interventionNames
- Other: [F-18]-FCH
- Radiation: PET scan
- Radiation: MRI scan
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Patient with CRPC and experiencing disease progression as defined by PCWG2 * ECOG 0-2 * Must continue gonadal castrative therapy * Has completed antiandrogen withdrawal ≥ 6 weeks prior to registration * Metastatic disease documented by imaging * Patient is planned for treatment with docetaxel or abiraterone * If treated with bisphosphonates or denosumab, has been on these for ≥ 6 weeks. * Must provide written informed consent Exclusion Criteria: * Prior history of invasive malignant disease unless disease free for at least 5 years, with the exception of non-melanoma skin cancer * Planned for any concurrent anticancer treatment oher than docetaxel or abiraterone * Prior radiotherapy or surgery within 4 weeks of start of docetaxel or abiraterone * Inability to comply with the imaging requirements (eg. inability to lie supine for one hour) * Allergy to MRI contrast agent or PET tracer to be used as part of the imaging * Sickle cell disease or other hemoglobinopathies * Insufficient renal function (eGFR ≤ 30 mL/min) * Known residual bladder volume \> 150 cc * Hip prosthesis or intrabdominal vascular grafting * Contraindication to CT contrast * Contraindication to MRI as per institutional policy
References
Publications (0)
Data not yet available