Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

Nanjing University

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer Metastatic Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06992232

IUNU-PC-122

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
3. Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
4. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
5. Patients must have adequate hematologic function, hepatic function and renal function.
6. 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.
7. Fertile patients must be willing to use highly effective contraception during the study period.

Exclusion criteria

1. Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
2. The researchers assessed the primary lesion as unresectable.
3. 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.
4. Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
5. 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.
6. Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.
7. 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.
8. Suffering from mental illness, mental disability, or being incapable of providing informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

144 participants in 2 patient groups

Intense androgen deprivation therapy (IADT)

Active Comparator group

Description:

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

Treatment:

Drug: Intense androgen deprivation therapy

Radiotherapy or Surgery plus IADT

Experimental group

Description:

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.

Treatment:

Radiation: Radiation Therapy

Drug: Intense androgen deprivation therapy

Procedure: radical prostatectomy