Clinical trial · Interventional
Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer
Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment
NCT03444844CI-TRIAL-00058200active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.
Conditions
Conditions (2)
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 |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68 P16-093 PET/CT scan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Biochemical recurrent prostate cancer
- description
- IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by whole body PET/CT scanning (pelvis to shoulders) for \~ 60 min (\~150 min for first 10 patients/dosimetry) starting immediately after injection. A contrast CT scan follows PET scan.
- interventionNames
- Drug: Ga-68 P16-093 PET/CT scan
- type
- EXPERIMENTAL
- label
- Intermediate/High Risk primary prostate cancer
- description
- IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by list mode PET/CT scanning using a fixed FOV including the pelvis area for \~ 50 min.
- interventionNames
- Drug: Ga-68 P16-093 PET/CT scan
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Cohort 1): * Male ≥ 18 years of age * Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease. * PSA ≥ 0.2 ng/mL * Patients must give informed consent for the research study, and agree to allow investigator access to clinical results following treatment plan implementation such as description of the treatment plan and PSA values following implementation of treatment plan as part of standard care, typically determined 3-4 months after treatment. Inclusion Criteria (Cohort 2): * Male ≥ 18 years of age * Histologically confirmed prostate cancer with following Gleason scoring at biopsy: * Gleason ≥ 4+3 OR * Gleason 3+4 with \>30% pattern 4 or ≥3 cores positive * Scheduled for radical prostatectomy (expected to occur within 60-days of scanning) * Patients must give informed consent for the research study, and agree to allow investigator access to the clinical results such as SOC imaging (mpMRI, e.g.) for surgical planning if done, or biopsy data following prostatectomy including lymph node dissection biopsy data, if available. Exclusion Criteria (Cohorts 1\& 2): * Inability to give informed consent. * Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia. * Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study
References
Publications (0)
Data not yet available
No reference posted for this study.