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Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer

NCT05212857 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-03-16

No results posted yet for this study

Summary

Oligo-metastatic prostate cancer (OMPCa) is considered as an intermediated state between localized and poly-metastatic disease. Various retrospective studies and prospective clinical trials are carrying out to validate whether patients with OMPCa could benefit from local treatment for both primary and metastatic lesions. The investigators here to conduct a unique clinical trial which OMPCa patients were confirmed by conventional imaging, and received a long-term enhanced systemic therapy accompanied by tumor-directed therapy.

Conditions

Interventions

DRUG

Leuprolide acetate

Given subcutaneously or as an injection

DRUG

Goserelin acetate

Given subcutaneously or as an injection

DRUG

Triptorelin acetate

Given subcutaneously or as an injection

DRUG

Degarelix acetate

Given subcutaneously or as an injection

DRUG

Abiraterone acetate

Given orally

DRUG

Apalutamide

Given orally

DRUG

Enzalutamide

Given orally

PROCEDURE

Local treatment for primary lesion

Radical prostatectomy to remove prostate primary lesion

RADIATION

Radiotherapy for primary lesion

Radical radiotherapy for primary lesion

RADIATION

Radiotherapy for metastatic lesion

Stereotactic body radiation therapy or proton and heavy ion radiation therapy is preferred, which could treat all the lesions at once or treat different lesions in stages.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Dingwei Ye, Doctoral · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2024-02-29
Completion
2024-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05212857 on ClinicalTrials.gov