RecruitingPhase 2NCT06387056

Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)

An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

40 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether genetic profiling of prostate cancer can guide which combination of hormone therapy drugs works best before surgery in men with locally advanced or limited-spread prostate cancer. The goal is to shrink the tumor before removing it. **You may be eligible if...** - You are male and 18 or older - Imaging has confirmed locally advanced or limited-spread (up to 5 bone sites) prostate cancer - You have not had bone or organ spread beyond those limits - You have not previously been treated for prostate cancer (short hormone therapy up to 28 days is allowed) - You are fit enough for surgery after the treatment period - You agree to genetic testing and contraception requirements during the study **You may NOT be eligible if...** - You have had brain metastases or epilepsy - You have had a heart attack, severe heart failure, or uncontrolled high blood pressure - You have had prostate surgery or radiation before - You have HIV, active hepatitis B, or untreated hepatitis C - You have other active cancers requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRezvilutamide

240mg by mouth once a day for 24 weeks.

DRUGGoserelin Microspheres for Injection

3.6mg by intramuscular injection once 4 weeks for 24 weeks.

DRUGDocetaxel

70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).

DRUGPamiparib

60mg by mouth twice a day for 20 weeks.

DRUGCisplatin

70mg/m2 by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).

DRUGTislelizumab

200 mg by infusion every 3 weeks for 6 cycles (each cycle has 3 weeks).


Locations(1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

View Full Details on ClinicalTrials.gov

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NCT06387056


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