Biodistribution and dosimetry of the investigational PET agent 68Ga-P16-093 in prostate cancer patients with biochemical recurrence undergoing clinical 68Ga-PSMA-11 PET/CT

Investigating Distribution and Radiation Exposure in Prostate Cancer

Recruiting
18 years - 100 years
Male
Phase N/A
1 Location

Brief description of study.

Whole body biodistribution and dosimetry with preliminary comparison to PSMA-11 in prostate cancer patients with biochemical recurrence

Detailed description of study

The primary purpose of the present research project is to determine the biodistribution of 68Ga-P16-093 in prostate cancer patients, and to assess associated patient radiation exposure based on our PET measures of organ uptake as a function of time. A secondary goal is to conduct a preliminary evaluation of the sensitivity and specificity of 68Ga-P16-093 compared to 68Ga-PSMA-11 to detect local or distant sites of recurrent disease.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: prostate cancer
  • Age: 18 years - 100 years
  • Gender: Male

Inclusion Criteria
Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease
Histologically confirmed prostate cancer with following Gleason scoring at biopsy
Scheduled for radical prostatectomy (expected to occur within 60-days of scanning)

Exclusion Criteria
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

Updated on 19 Feb 2024. Study ID: 1711061247 (RADY-FIVEELEV-GREEN-GA)

This study investigates the distribution of a substance called 68Ga-P16-093 in the bodies of prostate cancer patients who have experienced a return of cancer, known as biochemical recurrence. The purpose of this study is to understand how this substance spreads through the body and how much radiation patients are exposed to during this process. Researchers will use a special type of scan called PET to measure how much of the substance different organs absorb over time.

Participants will undergo PET scans to track the movement of 68Ga-P16-093 in their bodies. The study will also compare the effectiveness of this substance to another one, 68Ga-PSMA-11, in finding areas where the cancer might have returned. The PET scan is a procedure where a machine takes pictures of the inside of the body after a special substance is injected. This helps doctors see where the cancer might be.

  • Who can participate: Men with prostate cancer and rising PSA levels post-surgery are eligible. They must have confirmed prostate cancer and be scheduled for another surgery soon.
  • Study details: Participants will receive an injection of the investigational substance and then undergo PET scans. The scans will help determine how the substance moves through the body and how it compares to another similar substance in detecting cancer.

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