Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

Zhujiang Hospital

Status: Enrolling

Conditions: Prostate Cancer With ≤10 Bone Metastases

Treatments: Drug: Luteinizing Hormone-Releasing Hormone Analog; Drug: Apalutamide; Drug: 89Sr

Study type: Interventional

Funder types: Other

Identifiers

NCT05740488

2022-KY-241-02

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Prostate cancer confirmed by pathological findings;
2. Bone metastasis confirmed by bone scan, the number of bone metastases ≤10
3. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
4. ECOG score of 0 - 1
5. Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide therapy;
6. Voluntary signing of an ICF for the clinical trial

Exclusion criteria

1. Any other tumor disease requiring treatment;
2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
3. A history of epilepsy or any condition that may lead to seizures;
4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

apalutamide combined with 89Sr and ADT

Experimental group

Description:

Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT

Treatment:

Drug: 89Sr

Drug: Apalutamide

Drug: Luteinizing Hormone-Releasing Hormone Analog