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Recruiting NCT06992232

Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

Phase II Interventional Prostate Cancer Metastatic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intense androgen deprivation therapy, Radiation Therapy, radical prostatectomy.
Who it may be relevant to
Registry conditions: Prostate Cancer Metastatic Disease. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial

Overview

This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.

Interventions

  • Drug Intense androgen deprivation therapy
    Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.
  • Radiation Radiation Therapy
    Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. Radiation should be finished within 2 years' systemic therapy.
  • Procedure radical prostatectomy
    Those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Surgery should be finished within 2 years' systemic therapy.

Primary outcome measures

  • Event-free Survival [Time frame: 2 years]
Secondary outcome measures (3)
  • progression-free survival [Time frame: 4 years]
  • Time to CRPC [Time frame: 4 years]
  • Adverse events [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.
  • The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
  • Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
  • Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
  • Patients must have adequate hematologic function, hepatic function and renal 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 be willing 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.

Exclusion criteria

  • Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
  • The researchers assessed the primary lesion as unresectable.
  • Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.
  • Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
  • Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months.
  • Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.
  • Within the past 5 years, having had other malignant tumors except for prostate cancer, with the exception of cured basal or squamous cell skin cancer.
  • Suffering from mental illness, mental disability, or being incapable of providing informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institut — Nanjing

Identifiers

NCT: NCT06992232 · IUNU-PC-122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗