Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06387056

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

Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-04-26

40

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older
  • Signed informed consent according to local regulations
  • Imaging confirmed locally advanced (cT3b to cT4, N0 to N1, M0) or oligometastatic prostate cancer with no visceral metastasis and 5 or fewer bone metastases
  • Suitable for radical prostatectomy and pelvic lymph node dissection after neoadjuvant therapy and consent to undergo these surgeries
  • Histologically confirmed adenocarcinoma of the prostate without small cell or neuroendocrine differentiation
  • ECOG performance status 0 or 1 with life expectancy of 3 years or more
  • Adequate organ function with laboratory tests within 4 weeks before registration, including specified hemoglobin, white blood cell count, platelets, liver and renal function levels
  • Consent to genetic testing at registration
  • No prior systemic or localized prostate cancer treatment except up to 28 days of certain hormone therapies
  • Ability to swallow oral medication and comply with study procedures
  • Consent to use reliable contraception and avoid sperm donation during the study and for 3 months after last treatment
  • No contraindications to study drugs
Not Eligible

You will not qualify if you...

  • History of hypersensitivity to study drugs
  • More than 28 days of prior hormone therapy or enrollment in other therapeutic clinical studies within 28 days before enrollment
  • Prior local treatments on primary or metastatic lesions
  • Prior bilateral orchiectomy
  • Severe androgen deficiency defined by low serum testosterone
  • History of brain metastases or epilepsy
  • Severe cardiovascular disease including recent heart attack, unstable angina, severe heart failure, prolonged QT interval, or uncontrolled hypertension
  • Significant digestive tract issues affecting drug intake or absorption
  • Other significant co-morbidities making participation unsuitable
  • Other active cancers requiring treatment or malignancies within 5 years prior
  • Surgeries other than prostate biopsy within 4 weeks before enrollment
  • Active or detectable HIV, active hepatitis B or untreated hepatitis C
  • History of non-compliance with medical treatments or inappropriate for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361000

Actively Recruiting

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Research Team

K

Kaiyan Zhang, M.D.

CONTACT

H

Haichao Huang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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