Clinical trial · Interventional
Gallium-68 Citrate PET Used in Prostate Cancer
Gallium-68 Citrate PET To Detect MYC Amplification in Metastatic Castrate Resistant Prostate Cancer
- 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)
This is a single center, pilot, cross-sectional imaging study investigating the use of gallium-68 citrate PET in participants with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519). The study population will consist of participants with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-68 citrate | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gallium-68 citrate, PET
- description
- Participants will receive a single scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment received outside this study that will be completed within 12 weeks of baseline scan.
- interventionNames
- Drug: Gallium-68 citrate
- Procedure: Positron Emission Tomography (PET)
Primary outcomes (2)
- measure
- Mean maximum Standardized Uptake Value (SUVmax)
- timeFrame
- Day of imaging (1 day)
- description
- The mean and standard deviation of SUVmax of gallium-68 citrate (across all metastatic lesions per participant) will be reported.
- measure
- Mean maximum Standardized Uptake Value (SUVmax-ave)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male participants with histologically confirmed prostate cancer * Participants must have castrate levels of testosterone (\< 50 ng/dL) on Luteinizing hormone-releasing hormone (LHRH) analogue or have had prior bilateral orchiectomy, with evidence of castration-resistant disease by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria * Age 18 years or older at the time of study entry * Minimum of at least three discrete metastatic lesions in the bone and/or soft tissue amenable to whole body Positron Emission Tomography (PET) imaging per the judgment of study radiologist For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET: * Presence of one or more metastases by standard radiographic scans that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology Exclusion Criteria: * Contra-indications to MRI, including permanent pacemaker, implantable device, aneurysm clip, or severe claustrophobia (for participants planning to be imaged on PET/ Magnetic resonance imaging(MRI) scanner) * Active infection within 14 days of study enrollment For participants who undergo optional metastatic tumor biopsy following completion of gallium citrate PET: * History of radiation therapy to the target metastatic lesion selected for tumor biopsy * Contra-indication to biopsy including uncontrolled bleeding diathesis. * Platelets \>75,000/μl and prothrombin time (PT) or international normalized ratio (INR) and a partial prothrombin time (PTT) \< 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy.
References
Publications (0)
Data not yet available