An interventional study of Apalutamide and 89Sr in Prostate Cancer With ≤10 Bone Metastases, sponsored by Zhujiang Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Zhujiang Hospital · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 30 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
Drug: Apalutamide · Drug: 89Sr · Drug: Luteinizing Hormone-Releasing Hormone Analog
240mg, po, qd
100\~150MBq(based on weight), iv, q90d
sc, 3.6mg, q30d or 10.8mg, q90d
PFS
progression-free survival
Time frame: Up to 2 years after radical prostatectomy
pCR
pathological complete response
Time frame: Up to 1 year
rPFS
radiographic progression-free survival
Time frame: Up to 3 years
PSA response rate
more than 50% decrease from baseline
Time frame: Up to 3 years
pain score
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.
Time frame: Measured at baseline and follow up visits throughout the study, an average of 3 years
number and extent of bone metastases
Bone Scan
Time frame: Up to 3 years
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Zhujiang Hospital