Study Title

Phase 3 Trial of Copper Cu 64 PSMA I&T PET/CT Imaging in Men with Newly Diagnosed Prostate Cancer (Solar-Stage)

Study Details

Description:

Solar-Stage is a single-arm prospective study. Treating physicians will not be blinded to the imaging results. Local read of the copper Cu 64 PSMA I&T PET/CT can be used to inform patient management. For the co-primary endpoints, PET/CT scans will be read by blinded independent reviewers.

Sponsor:

Curium

Contacts:

Darcy Denner, Ph.D. (Clinical Trial Director)

darcy.denner@curiumpharma.com

Government Study Link:

NCT06235151 - Click here to see study on

ClinicalTrials.gov

Drug Details

Cu 64 PSMA I&T

Isotopes:

COPPER-64

Radioisotope: Cu-64

Theranostic Role: PET Imaging

T1/2 (Half-Life): 12.7 Hours

Decay Mode: POSITRON β+, BETA, Electron Capture, GAMMA

Energy: 0.65 MeV, Gamma 511 keV

Range: max 2.5mm, mean 0.7mm

Decay Daughters: Ni64 (Stable), Zn64 (Stable)

Status: FDA Approval: DETECTNET®

COPPER-64

Target: PSMA

Ligand: Small Molecules

Chelator: DOTAGA

Inclusion

Planned radical prostatectomy (RP) with pelvic lymph node dissection (PLND)
Unfavorable intermediate-risk, high-risk, or very-high-risk disease defined by NCCN Guidelines in Oncology Version 1
Male aged ≥18 years
Histologically proven prostate adenocarcinoma

Exclusion

ADT, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or investigational therapy in PC
PSMA PET within 90 days prior to enrollment

Patient Education

Publications

Publications Not Yet Provided

Locations

United States

XCancer - Omaha

17607 Gold Plaza, Omaha, Nebraska 68130, United States