Gallium-68 Citrate PET Used in Prostate Cancer

Plain-language summary

This study evaluated PET (positron emission tomography) imaging using Gallium-68 citrate in patients with prostate cancer. It enrolled male patients with castration-resistant disease. It was an Early Phase 1 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Early Phase 1

Status

Completed

Sponsor

Rahul Aggarwal

Intervention

Gallium-68 citrate, Positron Emission Tomography (PET)

Start date

5/28/2015

Estimated completion

6/15/2023

Countries

United States

Related genes

Locations

• San Francisco, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.