High-Risk and Oligometastatic Prostate CancerNCT04997252
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
A study testing Apalutamide in people with High-Risk and Oligometastatic Prostate Cancer, run by Zhujiang Hospital at 1 site in China.
Trial summary
The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High-Risk and Oligometastatic Prostate Cancer
- What is being tested?
- Apalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to Dec 2024
- 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
- Adult males aged above 18 years old, no healthy volunteers included;
- Prostate cancer confirmed by pathological findings;
- High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
- Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
- ECOG score of 0 - 1
- Agreement to undergo preoperative and postoperative endocrine 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 neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
- Being tested
- Apalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
apalutamide as neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| high-risk and oligometastatic prostate cance | Experimental | Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
rPFS
radiographic progression-free survival
Measured: Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Secondary outcomes (6)
pCR
pathological complete response
Measured: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PFS
positive margin rate; progression-free survival
Measured: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PSA response rate:
more than 50% decrease from baseline
Measured: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
TTPP
time to PSA progression
Measured: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
time to BCR after surgery
Measured: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
pathological stage
Measured: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Feb 2021
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk and Oligometastatic Prostate CancerStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binshen Chen, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997252
- Sponsor's protocol ID
- Chen-001
- Status last verified
- Mar 2024
- First submitted
- 29 Jul 2021
- Last updated
- 18 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT04997252
- Acronym / sponsor ID
- Chen-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Aug 2021 (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 neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-risk and oligometastatic prostate cance | Experimental | Drug: ApalutamideNeoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult males aged above 18 years old, no healthy volunteers included;
- Prostate cancer confirmed by pathological findings;
- High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
- Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
- ECOG score of 0 - 1
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 |
|---|---|---|
| Apalutamideapalutamide as neoadjuvant therapy | Drug | high-risk and oligometastatic prostate cance |
Primary outcome
rPFS
Time frame: Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
radiographic progression-free survival
6 secondary outcomes
pCR
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PFS
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PSA response rate:
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
TTPP
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
time to BCR after surgery
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
pathological stage
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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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.
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 in people with High-Risk and Oligometastatic Prostate Cancer, 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 7 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 18 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, 59281481@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rPFS (time frame: Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.). 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 18 Mar 2024.