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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05740488

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer With ≤10 Bone Metastases	Drug: Apalutamide Drug: 89Sr Drug: Luteinizing Hormone-Releasing Hormone Analog	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: apalutamide combined with 89Sr and ADT Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT	Drug: Apalutamide 240mg, po, qd Drug: 89Sr 100~150MBq(based on weight), iv, q90d Drug: Luteinizing Hormone-Releasing Hormone Analog sc, 3.6mg, q30d or 10.8mg, q90d

Arm

Intervention/Treatment

Experimental: apalutamide combined with 89Sr and ADT

Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT

Drug: Apalutamide

240mg, po, qd

Drug: 89Sr

100~150MBq(based on weight), iv, q90d

Drug: Luteinizing Hormone-Releasing Hormone Analog

sc, 3.6mg, q30d or 10.8mg, q90d

Outcome Measures

Primary Outcome Measures

PFS [Up to 2 years after radical prostatectomy]
progression-free survival

Secondary Outcome Measures

pCR [Up to 1 year]
pathological complete response
rPFS [Up to 3 years]
radiographic progression-free survival
PSA response rate [Up to 3 years]
more than 50% decrease from baseline
pain score [Measured at baseline and follow up visits throughout the study, an average of 3 years]
Measurement of pain assessed by a Visual Analogue Scale (VAS). The analogous visual scale used for this study measures from 0 to 10 the intensity of pain with a series of "faces" that show the intensity in the pain experimentation with categories such as "No pain" in number 0, mild in number 1-3, moderate in number 4-6, intense in number 7-9 and worst in number 10.
number and extent of bone metastases [Up to 3 years]
Bone Scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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