Radiotherapy or Surgery Combined With Intense Androgen De... | NCT06992232

Status Module

Name	Class
The First Affiliated Hospital of Soochow University	OTHER
Peking University First Hospital	OTHER

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intense androgen deprivation therapy	Drug	Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.	Intense androgen deprivation therapy (IADT)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
progression-free survival	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.

Eligibility Module

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.

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Junlong Zhuang, PhD	Contact	+86 15950451917		zhuangjl-2008@163.com
Hongqian Guo, PhD	Contact

Name	Affiliation	Role
Hongqian Guo, PhD	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Recruiting	Nanjing	Jiangsu	210008	China

ID	Term
D000726	Androgen Antagonists
D011878	Radiotherapy

ID	Term
D006727	Hormone Antagonists
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D013812	Therapeutics