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An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer

An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer

Recruiting
18 years and older
Male
Phase N/A

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Overview

The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.

Eligibility

Inclusion Criteria:

  1. Adult males aged above 18 years old, no healthy volunteers included;
  2. Prostate cancer confirmed by pathological findings;
  3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
  4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
  5. ECOG score of 0 - 1
  6. Agreement to undergo preoperative and postoperative endocrine therapy;
  7. Voluntary signing of an ICF for the clinical trial

Exclusion Criteria:

  1. Any other tumor disease requiring treatment;
  2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
  3. A history of epilepsy or any condition that may lead to seizures;
  4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.

Study details
    High-Risk and Oligometastatic Prostate Cancer

NCT04997252

Zhujiang Hospital

19 March 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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