XCancer

PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC

Description:

This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy. Participants whose cancer has not progressed and who still have active tumor lesions on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) will then be randomly assigned to one of two groups. One group will continue darolutamide plus androgen deprivation therapy. The other group will receive stereotactic body radiotherapy (SBRT) to all active tumor lesions identified by PSMA PET/CT, while continuing darolutamide plus androgen deprivation therapy. The main purpose of this study is to find out whether adding PSMA PET/CT-guided SBRT can help participants live longer without tumor growth seen on scans or death. The study will also evaluate prostate-specific antigen (PSA) changes, time to castration-resistant prostate cancer, overall survival, side effects, and quality of life.

Sponsor:

Huashan Hospital

Phase:

Phase 2

Contacts:

Hao Zeng, MD, PhD (CONTACT)

kucaizeng@163.com

86 28 85422026

Hao Zeng, MD, PhD (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT07649421 - Click here to see study on

ClinicalTrials.gov

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
Inclusion
  • No neuroendocrine carcinoma, ductal adenocarcinoma, small-cell carcinoma, signet-ring cell carcinoma, or sarcomatoid carcinoma component.
  • * Male participants aged ≥18 years and \<85 years.
  • PSMA PET/CT and FDG PET/CT show ≤20 metastatic lesions.
  • Histologically confirmed prostate adenocarcinoma.
  • Metastatic prostate cancer confirmed by imaging or pathological evidence.
Exclusion
  • * Current or prior history of another primary malignancy.
  • History of another malignancy within 3 years that differs from the study cancer in primary site or histology.
  • History of papillary thyroid carcinoma is allowed if it is well controlled.
  • History of squamous cell carcinoma of the skin is allowed if it is well controlled.
  • History of basal cell carcinoma of the skin is allowed if it is well controlled.