Prostate CancerPhase 1/2LUMA-PSMANCT06906471
A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS
A Phase 1/2 study testing AS1986NS in people with Prostate Cancer and Prostate Cancer (Adenocarcinoma), run by Antelope Surgical Solutions, Inc at 2 sites in United States.
Trial summary
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer (Adenocarcinoma), Fluorescence Imaging
- What is being tested?
- AS1986NS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2026to 30 Nov 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected prostate cancer warranting standard of care multi-core prostate biopsy
Who cannot join
- Patients receiving same-day therapeutic Lutetium-177 or Actinium-225 PSMA receptor radiation isotope therapy treatment
- Patients with pre-existing, impaired or abnormal hepatic function, renal function, cardiac function, and abnormal elevated temperature
- Patients with a creatinine clearance cutoff (CrCl) of < 60 mL/min
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HCA Florida Kendall Hospital
Miami, Florida, 33175
Icahn School of Medicine at Mount Sinai (ISMMS)
New York, New York, 10029
About this study
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
- Being tested
- AS1986NS
- Keywords
- fluorescent agent, PSMA, prostate surface membrane antigen, histopathology, fluorescence-guided surgery
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS1986NSDrug
Single dose, IV, 100 µg of AS1986NS
| Study group | Role | What they receive |
|---|---|---|
| Single dose of AS1986NS | Experimental | Single dose of AS1986NS administered as an injection through peripheral intravenous access. Receives: Drug: AS1986NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of AS1986NS
Demonstrate that AS1986NS is 'safe' as a microdosed <100 µg, <100 µL, 1 mg/mL per patient dose when introduced intravenously as a bolus through peripheral intravenous access by evaluation of the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with AS1986NS
Measured: Enrollment to 30 days post single infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jul 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antelope Surgical Solutions, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906471
- Sponsor's protocol ID
- 173786_007_1
- Acronym
- LUMA-PSMA
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Publications
Kommidi H, Guo H, Nurili F, Vedvyas Y, Jin MM, McClure TD, Ehdaie B, Sayman HB, Akin O, Aras O, Ting R. 18F-Positron Emitting/Trimethine Cyanine-Fluorescent Contrast for Image-Guided Prostate Cancer Management. J Med Chem. 2018 May 10;61(9):4256-4262. doi: 10.1021/acs.jmedchem.8b00240. Epub 2018 Apr 20.
PubMed 29676909Guo H, Kommidi H, Vedvyas Y, McCloskey JE, Zhang W, Chen N, Nurili F, Wu AP, Sayman HB, Akin O, Rodriguez EA, Aras O, Jin MM, Ting R. A Fluorescent, [18F]-Positron-Emitting Agent for Imaging Prostate-Specific Membrane Antigen Allows Genetic Reporting in Adoptively Transferred, Genetically Modified Cells. ACS Chem Biol. 2019 Jul 19;14(7):1449-1459. doi: 10.1021/acschembio.9b00160. Epub 2019 Jun 17.
PubMed 31120734Aras O, Demirdag C, Kommidi H, Guo H, Pavlova I, Aygun A, Karayel E, Pehlivanoglu H, Yeyin N, Kyprianou N, Chen N, Harmsen S, Sonmezoglu K, Lundon DJ, Oklu R, Ting R, Tewari A, Akin O, Sayman HB. Small Molecule, Multimodal, [18F]-PET and Fluorescence Imaging Agent Targeting Prostate-Specific Membrane Antigen: First-in-Human Study. Clin Genitourin Cancer. 2021 Oct;19(5):405-416. doi: 10.1016/j.clgc.2021.03.011. Epub 2021 Mar 19.
PubMed 33879400