Prostate Cancer With ≤10 Bone MetastasesNCT05740488
Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
A study testing Apalutamide, 89Sr and Luteinizing Hormone-Releasing Hormone Analog in people with Prostate Cancer With ≤10 Bone Metastases, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer With ≤10 Bone Metastases
- What is being tested?
- Apalutamide, 89Sr and Luteinizing Hormone-Releasing Hormone Analog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510200
yiming zhang
About this study
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.
- Conditions
- Prostate Cancer With ≤10 Bone Metastases
- Being tested
- Apalutamide, 89Sr, Luteinizing Hormone-Releasing Hormone Analog
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
240mg, po, qd
89SrDrug
100~150MBq(based on weight), iv, q90d
Luteinizing Hormone-Releasing Hormone AnalogDrug
sc, 3.6mg, q30d or 10.8mg, q90d
| Study group | Role | What they receive |
|---|---|---|
| apalutamide combined with 89Sr and ADT | Experimental | Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT Receives: Drug: Apalutamide; Drug: 89Sr; Drug: Luteinizing Hormone-Releasing Hormone Analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: Up to 2 years after radical prostatectomy
Secondary outcomes (5)
pCR
pathological complete response
Measured: Up to 1 year
rPFS
radiographic progression-free survival
Measured: Up to 3 years
PSA response rate
more than 50% decrease from baseline
Measured: 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.
Measured: Measured at baseline and follow up visits throughout the study, an average of 3 years
number and extent of bone metastases
Bone Scan
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start7 Jan 2022
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer With ≤10 Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binshen Chen, Zhujiang Hospital
- Investigators
- Chen Binshen, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740488
- Sponsor's protocol ID
- 2022-KY-241-02
- Status last verified
- Mar 2024
- First submitted
- 8 Feb 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
- ClinicalTrials.gov ID
- NCT05740488
- Acronym / sponsor ID
- 2022-KY-241-02
- Conditions
- Prostate Cancer With ≤10 Bone Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apalutamide combined with 89Sr and ADT | Experimental | Drug: Apalutamide, Drug: 89Sr, Drug: Luteinizing Hormone-Releasing Hormone AnalogNeoadjuvant therapy with apalutamide in combination with 89Sr and ADT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apalutamide240mg, po, qd | Drug | apalutamide combined with 89Sr and ADT |
| 89Sr100~150MBq(based on weight), iv, q90d | Drug | apalutamide combined with 89Sr and ADT |
| Luteinizing Hormone-Releasing Hormone Analogsc, 3.6mg, q30d or 10.8mg, q90d | Drug | apalutamide combined with 89Sr and ADT |
Primary outcome
PFS
Time frame: Up to 2 years after radical prostatectomy
progression-free survival
5 secondary outcomes
pCR
Time frame: Up to 1 year
rPFS
Time frame: Up to 3 years
PSA response rate
Time frame: Up to 3 years
pain score
Time frame: Measured at baseline and follow up visits throughout the study, an average of 3 years
number and extent of bone metastases
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Binshen study chair
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apalutamide, 89Sr and Luteinizing Hormone-Releasing Hormone Analog in people with Prostate Cancer With ≤10 Bone Metastases, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Yiming (020-62782726, 359281481@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to 2 years after radical prostatectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.