Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorNorroy Bioscience Co., LTD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 68-Ga-NYM032

    Drug

    IV injection

Treatment groups

365 Participants
are divided into 1 treatment group
Group A: 68-Ga-NYM032Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
up to 30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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