NCT04857502 99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
| NCT ID | NCT04857502 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-04-27 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2021-04-27 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jeremie Calais, MD
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT04857502 clinical trial?
This trial is open to male participants only, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04857502 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04857502 currently recruiting?
Yes, NCT04857502 is actively recruiting participants. Contact the research team at DVarughese@mednet.ucla.edu for enrollment information.
Where is the NCT04857502 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04857502 clinical trial?
NCT04857502 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Jeremie Calais, MD at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 30 participants.