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Radioisotope
99mTc-PSMA Imaging for Prostate Cancer
Phase < 1
Recruiting
Led By Jeremie Calais, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men with PCa (primary or recurrent disease)
Men who can provide oral and written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from injection to imaging (range: 1-46 hours)
Awards & highlights
Study Summary
This trial is testing a PSMA-targeted radioisotope called 99mTc-PSMA-I&S to see if it can help guide doctors to detect prostate cancer that has spread to the lymph nodes.
Who is the study for?
This trial is for men with prostate cancer (new or recurring) who are set to have surgery to remove lymph nodes in the pelvis. They must show positive lymph node disease on a specific PET/CT scan and be able to follow study procedures. Men already treated for prostate cancer between enrollment and surgery, or with hard-to-reach nodal locations can't join.Check my eligibility
What is being tested?
The study tests a new method using an imaging agent called 99mTc-PSMA-I&S during surgery to see if it helps find and guide the removal of cancerous lymph nodes by emitting a signal that doctors can detect with special equipment.See study design
What are the potential side effects?
As this is an exploratory study focusing on imaging techniques, side effects may include reactions related to the injection of the imaging agent such as mild pain or discomfort at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man with prostate cancer (either newly diagnosed or recurrent).
Select...
I am a man who can understand and agree to the study's terms.
Select...
I am a man scheduled for surgery to remove lymph nodes in my pelvis.
Select...
My PET/CT scan shows lymph node involvement in my cancer.
Select...
I am a man who had a PSMA PET/CT scan for cancer staging.
Select...
I am a man who can follow the study's requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from injection to imaging (range: 1-46 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from injection to imaging (range: 1-46 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)
Secondary outcome measures
99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts/minute) and level of PSMA expression quantified by histopathology (IHC score)
The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (99mTc-PSMA-I&S, SPECT/CT)Experimental Treatment3 Interventions
The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I&S IV before standard of care surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,046 Total Patients Enrolled
38 Trials studying Prostate Cancer
3,970 Patients Enrolled for Prostate Cancer
Jeremie Calais, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
5 Previous Clinical Trials
152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man with prostate cancer (either newly diagnosed or recurrent).My cancer has spread to a place doctors can't easily reach.I started prostate cancer treatment between joining the study and surgery.I am a man who can understand and agree to the study's terms.I am a man scheduled for surgery to remove lymph nodes in my pelvis.My PET/CT scan shows lymph node involvement in my cancer.I am a man who had a PSMA PET/CT scan for cancer staging.I am a man who can follow the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any spaces remaining for recruitment into this clinical trial?
"This clinical trial is currently in the recruitment phase, with its initial posting made on April 27th 2021 and most recent update conducted on July 21st 2022."
Answered by AI
What is the scope of recruitment for this trial?
"Absolutely. The information made available on clinicaltrials.gov displays that this medical trial, first announced April 27th 2021, is currently recruiting participants. 30 patients are sought after from a single location."
Answered by AI
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