TheranosticTrials.org

Clinical Trial · NCT05707468

Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Overview

The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.

Sponsor

Zhongda Hospital

Phase

N/A

Contacts

Xianzhi Zhao, MD (CONTACT)

zhxzh0007@163.com

021-31162222

Huojun Zhang, PhD (CONTACT)

huojunzh@163.com

021-31162222

ClinicalTrials.gov

NCT05707468

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • World Health Organization (WHO) performance status 0-1
  • \<4 bone oligometastases, lymph node metastasis below the renal artery level
  • Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT
  • Histologically confirmed adenocarcinoma of the prostate without small cell features

Exclusion

  • Patients who have participated in other clinical trials within the last 3 months
  • Patients who have undergone other abdominal surgery within the last 3 months
  • Patients who refuse to undergo RALP
  • Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration
  • Severe or active comorbidities likely to impact the advisability of radiotherapy
  • Patients who have previously undergone transurethral resection or enucleation of the prostate.
  • Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.
  • Patients who have visceral metastases