Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

NCT06992232 | Recruiting Phase 2

• 1 other identifier: IUNU-PC-122
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer Metastatic Disease

Keywords

metastatic prostate cancer; radiotherapy; prostatectomy

Outcome Measures

Primary Outcomes (1)

• Event-free Survival

  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.

  2 years

Secondary Outcomes (3)

• progression-free survival

  4 years

• Time to CRPC

  4 years

• Adverse events

  4 years

Study Arms (2)

Intense androgen deprivation therapy (IADT)

ACTIVE COMPARATOR

Patients received ADT plus ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years in the Intense androgen deprivation therapy (IADT) group.

Drug: Intense androgen deprivation therapy

Radiotherapy or Surgery plus IADT

EXPERIMENTAL

For patients in the experimental group, local treatment either radiotherapy or surgery was arranged in addition to systemic ADT plus ARi. 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. While those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment.

Drug: Intense androgen deprivation therapy; Radiation: Radiation Therapy; Procedure: radical prostatectomy

Interventions

Intense androgen deprivation therapy DRUG

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

Also known as: ADT plus second-generation ARi

Intense androgen deprivation therapy (IADT); Radiotherapy or Surgery plus IADT

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.

Radiotherapy or Surgery plus IADT

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.

Radiotherapy or Surgery plus IADT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• The First Affiliated Hospital of Soochow University: collaborator
• Peking University First Hospital, Beijing, CHINA: collaborator

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Study Officials

• Hongqian Guo, PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junlong Zhuang, PhD

CONTACT

+86 15950451917; zhuangjl-2008@163.com

Hongqian Guo, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)