NCT07615101

Brief Summary

The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P50-P75 for phase_3

Timeline
12mo left

Started Jun 2026

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jun 2026Jul 2027

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 22, 2026

Last Update Submit

May 28, 2026

Conditions

Prostate Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity

    Assessing the sensitivity and specificity of 68Ga-NYM032 Injection positron emission tomography (PET) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.

    up to 30 days

Study Arms (1)

68-Ga-NYM032

EXPERIMENTAL
Drug: 68-Ga-NYM032

Interventions

68-Ga-NYM032DRUG

IV injection

68-Ga-NYM032

Eligibility Criteria

Age18 Days+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is male and aged \>18 years old.
  • Biopsy proven prostate adenocarcinoma.
  • Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
  • ECOG performance status 0-2; expected survival ≥ 6 months.
  • \. Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

  • \. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.
  • \. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
  • \. Known hypersensitivity to the active ingredient or excipients of the study drug.
  • \. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
  • \. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05