NCT03444844Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 2 May 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Feb 2018
- Start date
- 10 May 2018
- Primary completion date
- 27 Oct 2020
- Lead sponsor
- Five Eleven Pharma, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT03444844
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 10 May 2018 to the primary completion date, 27 Oct 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.