99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
Status
RECRUITING
Phase
EARLY_PHASE1
Age
All Ages
Enrollments
30Conditions
Prostate Carcinoma, Recurrent Prostate CarcinomaDrugs
99mTc-based PSMA Imaging and Surgery AgentSummary
This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.
Detailed Description
PRIMARY OBJECTIVE:
I. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.
SECONDARY OBJECTIVES:
I. To correlate the 99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.
II. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I&S administration.
OUTLINE:
The first 5 patients receive an initial dose of 99mTc-PSMA-I&S intravenously (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 surgery.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Deepu Varughese
- 310-206-7372
- [email protected]
Principal Investigator
- Jeremie Calais, MD
Eligibility Criteria
Inclusion Criteria:
* Men with PCa (primary or recurrent disease)
* Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
* Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
* Men who are scheduled for pelvic LN dissection (PLND)
* Men who can provide oral and written informed consent
* Men who can comply with study procedures
Exclusion Criteria:
* Patients who started any PCa treatment between study enrollment and surgery
* Technically inaccessible nodal location
Outcome Measures
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
Timeline
Last Updated
November 5, 2024Start Date
April 23, 2021Today
January 16, 2025Completion Date ( Estimated )
June 1, 2026
Sponsors of this trial
Lead Sponsor
Jonsson Comprehensive Cancer Center
RECRUITING 
21 - 64 Years