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NCT Number: NCT06992232

Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, 210008, China

Location status: Recruiting

Location contact

Junlong Zhuang, MD

CONTACT

[email protected]

8615950451917

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intense androgen deprivation therapy

Drug

Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.

Other names: ADT plus second-generation ARi

radiation therapy

Radiation

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.

radical prostatectomy

Procedure

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 outcomes

  1. Event-free Survival

    Time frame: 2 years

    Following 2 years of treatment, any anti-tumor treatment was terminated for those who met complete remission until two consecutively rised PSA>0.2ng/ml. Complete remission is interpreted as PSA level<0.1ng/ml and absence of radiographic as well as clinical progression following the 2-year treatment, both are indispensable. The primary outcome was event-free survival (EFS), defined as the time from disease complete remission to any required anti-tumor treatment.

Secondary outcomes

  1. progression-free survival

    Time frame: 4 years

    Defined as from treatment initiation to PSA progression or radiographic/clinical progression. PSA progression is defined as PSA >1 ng/ml, with two consecutive PSA measurements at least one week apart showing a 50% or greater increase from baseline). Radiographic progression is defined as development of two or more new bone metastases or progression of soft tissue lesions according to RECIST 1.1 criteria. Clinical progression is defined as worsening clinical symptoms and signs as determined by the physician.

  2. Time to CRPC

    Time frame: 4 years

    Time to CRPC (castration-resistant prostate cancer (CRPC) is calculated from treatment initiation to the development of CRPC. CRPC is defined as serum testosterone at castration level (<50 ng/dl or 1.7 nmol/l), while meeting one of the following criteria: a. Biochemical progression: Three consecutive PSA rises, each measured at least one week apart, with at least two increases exceeding 50% above baseline, and at least one PSA value >2 ng/ml. b. Radiographic progression: Development of two or more new bone metastases, or progression of soft tissue lesions according to RECIST criteria.

  3. Adverse events

    Time frame: 4 years

    valuate all adverse events (AEs) and grade them according to NCI-CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongqian Guo, PhD

CONTACT

Junlong Zhuang, PhD

CONTACT

[email protected]

+86 15950451917

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • Peking University First Hospital
  • The First Affiliated Hospital of Soochow University

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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