XCancer
Curium

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

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

Cu 64 PSMA I&T

Isotope(s):
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

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