Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Официальное название

A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Обзор

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

Подробное описание

The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.

Вмешательства

• Препарат ADT
  The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect.
• Препарат Abiraterone Acetate
  1000 mg (250 mg×4 tablets) once daily, orally
• Препарат Prednisolone tablets
  5 mg once daily, orally.
• Препарат Enzalutamide
  160 mg (40 mg× 4 tablets) once daily, orally.
• Препарат Apalutamide
  240 mg (60 mg×4 tablets) once daily, orally.
• Препарат Darotamide
  600 mg (300 mg × 2 tablets) twice daily, orally.
• Препарат Rezvilutamide
  240 mg (80 mg × 3 tablets) once daily orally
• Препарат PARP inhibitor
  The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.
• Процедура Robot-assisted radical prostatectomy
  Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

Первичные конечные точки

• Pathologic response rate [Срок оценки: up to 3 years]
• 3 year biochemical progression free survival (bPFS) [Срок оценки: up to 3 years]

Вторичные конечные точки (6)

• Metastasis-Free Survival (MFS) [Срок оценки: up to 5 years]
• Time to castration-resistant prostate cancer（CRPC) [Срок оценки: up to 5 years]
• PSA response rate [Срок оценки: up to 3 years]
• Positive margin rate [Срок оценки: up to 6 months]
• Pathologic downgrade rate [Срок оценки: up to 6 months]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

• All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
• All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1).
• Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
• Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
• Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must bewilling to obey the prohibitions and restrictions specified in the research protocol.
• Fertile patients must be willing to use highly effective contraception during the study period and within 120 days of the last dose of treatment.

Критерии исключения

• Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
• Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3; b) Gleason score of primary tumor < 8; c) prostate specific antigen (PSA) <20 ng/ml.
• Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.
• Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.
• Patients with severe or uncontrolled concurrent infections are not eligible.
• Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
• Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
• Patients with mental illness, mental disability or inability to give informed consent are not eligible.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institut — Нанкин

Идентификаторы

NCT: NCT05406999 · IUNU-PC-118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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