NCT04857502RecruitingEarly phase 1
99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 1 Apr 2021
- Start date
- Apr 2021
- Primary completion date
- Jun 2027
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT04857502
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From Apr 2021 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who started any PCa treatment between study enrollment and surgery
Other
- Technically inaccessible nodal location
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.