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:
CuriumContacts:
Darcy Denner, Ph.D. (Clinical Trial Director)darcy.denner@curiumpharma.com
Government Study Link:
NCT06235151 - Click here to see study onClinicalTrials.gov
Drug Details
Cu 64 PSMA I&T
Isotope(s):
- COPPER-64
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®
Target(s):
- 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