Metastatic Prostate CancerPhase 3NCT06350825
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
A Phase 3 study testing Cytoreductive prostatectomy or brachytherapy and ADT+second-generation antiandrogens ± chemotherapy in people with Metastatic Prostate Cancer and Therapy, Directly Observed, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP) Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Therapy, Directly Observed
- What is being tested?
- Cytoreductive prostatectomy or brachytherapy and ADT+second-generation antiandrogens ± chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male aged ≥18 and ≤75;
- Histologically confirmed prostate adenocarcinoma;
- Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
- Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
- Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
- The surgeon believes the prostate can be removed;
Who cannot join
- The surgeon believes the disease is unresectable;
- Life expectancy less than 2 years;
- Active spinal cord compression;
- History of prior local treatment for prostate cancer;
- Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
- Refusal to sign the informed consent;
- Investigator believes the individual is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Shangqian Wang, M.D., 13770561625, wsq5501@126.com
Lixin Hua, M.D.
About this study
Official title: Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
Read the detailed description
To investigate the multimodality approaches for mHSPC
- Being tested
- Cytoreductive prostatectomy or brachytherapy, ADT+second-generation antiandrogens ± chemotherapy
- Keywords
- prostate cancer, cytoreductive prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive prostatectomy or brachytherapyProcedure or surgery
Also called surgery or radiation therapy+SOC
local treatment+SOC for metastatic prostate cancer
ADT+second-generation antiandrogens ± chemotherapyDrug
Also called hormonal therapy or chemotherapy
SOC(Triplet or doublet therapy) for mHSPC
| Study group | Role | What they receive |
|---|---|---|
| Local treatment group | Experimental | Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy Receives: Procedure: Cytoreductive prostatectomy or brachytherapy |
| SOC group | Active comparator | Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide) Receives: Drug: ADT+second-generation antiandrogens ± chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rPFS
Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence
Measured: 3 year
Secondary outcomes (1)
Safety of CRP in mHSPC patients
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: until one year after the local therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Lixin, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Lixin Hua, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350825
- Sponsor's protocol ID
- 2023-SR-543
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT06350825
- Acronym / sponsor ID
- 2023-SR-543
- Keywords
- prostate cancer, cytoreductive prostatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Apr 2024 (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.
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
Detailed description
To investigate the multimodality approaches for mHSPC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control
| Arm | Type | Receives |
|---|---|---|
| Local treatment group | Experimental | Procedure: Cytoreductive prostatectomy or brachytherapyTriplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy |
| SOC group | Active comparator | Drug: ADT+second-generation antiandrogens ± chemotherapyTriplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male aged ≥18 and ≤75;
- Histologically confirmed prostate adenocarcinoma;
- Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
- Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
- Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
Key exclusion criteria (7 listed)
- The surgeon believes the disease is unresectable;
- Life expectancy less than 2 years;
- Active spinal cord compression;
- History of prior local treatment for prostate cancer;
- Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
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 |
|---|---|---|
| Cytoreductive prostatectomy or brachytherapyAlso: surgery or radiation therapy+SOClocal treatment+SOC for metastatic prostate cancer | Procedure or surgery | Local treatment group |
| ADT+second-generation antiandrogens ± chemotherapyAlso: hormonal therapy or chemotherapySOC(Triplet or doublet therapy) for mHSPC | Drug | SOC group |
Primary outcome
rPFS
Time frame: 3 year
Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence
1 secondary outcome
Safety of CRP in mHSPC patients
Time frame: until one year after the local therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Lixin Hua, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytoreductive prostatectomy or brachytherapy and ADT+second-generation antiandrogens ± chemotherapy in people with Metastatic Prostate Cancer and Therapy, Directly Observed, run by The First Affiliated Hospital with Nanjing Medical University 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 7 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: looking for participants now, as of the sponsor's last update on 5 Apr 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lixin Hua, M.D. (13072564303, hlx5858@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rPFS (time frame: 3 year). 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 5 Apr 2024.