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
M
Mark Green
Primary Investigator
Administratively Closed
18 years - 100 years
Male
Phase
1/2
1 Location
Brief description of study
What is the purpose of this 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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
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 (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.
- 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
Updated on
01 Aug 2024.
Study ID: RADY-FIVEELEVEN-GREEN-GA, 1711061247
