ProstatectomyPhase 2NCT04992026
The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer
A Phase 2 study testing robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection, 1.Abiraterone Acetate Tablets and Prednisone Acetate Tablets in people with Prostatectomy and Oligometastatic Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostatectomy, Oligometastatic Prostate Cancer, Abiraterone
- What is being tested?
- robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection, 1.Abiraterone Acetate Tablets and Prednisone Acetate Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 2 Dec 2024
- Phase
- Phase 2
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 40 and ≤75 years of age.
- All patients must have a histologically or cytologically diagnosis of prostate cancer.
- All patients must have been diagnosed oligometastatic prostate cancer which meet the following criteria. (1) ≤5 metastatic lesions are found by imaging examination (2)No visceral metastasis was found (3) The diameter of a single lesion ≤5cm or the surface area ≤250cm2.
- Patients previously treated with surgical castration or androgen deprivation therapy must maintain a testosterone level of <50ng/dl or <1.7nmol/L during treatment. Also the treatment duration should be less than 9 months. Patients were previously treated with at least 6 cycles of abiraterone.
- PSA<2ng/ml before enrollment.
- There was no PSA progression or radiographic progression during previous treatment.
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- Primary lesion must be eligible for radical prostatectomy based on random radiographic assessment. ( Preoperative clinical staging <T4 or achievable complete resection agreed by experienced surgeons is deemed as eligible for radical prostatectomy)
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
- Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by: white blood cell (WBC) ≥ 4.0 × 109 /L, platelets≥ 100 × 109 / L, hemoglobin ≥ 9g / dL, and international normalized ratio (INR) < 1.5.
- Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN),and SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN.
- Patients must have adequate renal function, within 28 days prior toregistration, as evidenced by serum creatinine ≤2×ULN
- Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
Who cannot join
- Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
- Patients with visceral metastasis or more than 5 metastatic lesions are excluded.
- Patients were diagnosed metastatic castration-naive prostate cancer for more than 9 months or showed biochemical or radiographic progression before enrollment.
- Patients with unresectable primary lesion before enrollment based on CT/MRI.
- Patients received local treatments such as pre-focal treatment, radiotherapy and palliative endoscopic resection.
- Patients with severe or uncontrolled concurrent infections are not eligible.
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- Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration.
- Patients must not have uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- Patients must not have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
- Patients with mental illness, mental disability or inability to give informed consent are not eligible.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu
About this study
Official title: A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer
This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer
- Conditions
- Prostatectomy, Oligometastatic Prostate Cancer, Abiraterone
- Being tested
- robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection, 1.Abiraterone Acetate Tablets, Prednisone Acetate Tablets, Luteinizing Hormone-Releasing Hormone Analog
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissectionProcedure or surgery
Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed.
1.Abiraterone Acetate TabletsDrug
1000mg(4 tablets, 250mg per tablet) daily for 6 cycles
Prednisone Acetate TabletsDrug
5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets
Luteinizing Hormone-Releasing Hormone AnalogDrug
Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.
| Study group | Role | What they receive |
|---|---|---|
| ADT plus abiraterone + surgery | Experimental | After 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery. Receives: Procedure: robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection; Drug: 1.Abiraterone Acetate Tablets; Drug: Prednisone Acetate Tablets; Drug: Luteinizing Hormone-Releasing Hormone Analog |
| ADT plus abiraterone | Active comparator | Patients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed. Receives: Drug: 1.Abiraterone Acetate Tablets; Drug: Prednisone Acetate Tablets; Drug: Luteinizing Hormone-Releasing Hormone Analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to PSA progression progression
PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.
Measured: up to 2 years
Time to Radiographic progression
Radiographic progression is defined as newly discovered soft tissue metastasis according to the RECIST 1.1 or at least 2 bone lesions.
Measured: up to 2 years
Secondary outcomes (4)
rPFS (radiographic progression free survival)
The time of radiographic progression free survival
Measured: up to 2 years
Time to castration resistance
The time to castration resistance
Measured: up to 2 years
Time to PSA remission (≥50%) and time to PSA remission (≥90%)
Time to the point when PSA drop to below 50% initial PSA level. Time to the point when PSA drop to below 10% initial PSA level.
Measured: up to 2 years
Time to new anti-cancer treatment
Time to the point when onther anti-cancer treatment is necessary
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, The First People's Hospital of Changzhou, The First Affiliated Hospital of Soochow University, Wuxi People's Hospital, Affiliated Hospital of Nantong University, Yangzhou University
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Hongqian Guo, MD, Principal investigator, Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992026
- Sponsor's protocol ID
- IUNU-PC-108
- Status last verified
- Dec 2024
- First submitted
- 28 Jul 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT04992026
- Acronym / sponsor ID
- IUNU-PC-108
- Conditions
- Prostatectomy, Oligometastatic Prostate Cancer, Abiraterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, The First People's Hospital of Changzhou, The First Affiliated Hospital of Soochow University, Wuxi People's Hospital, Affiliated Hospital of Nantong University, Yangzhou University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 5 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.
This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT plus abiraterone + surgery | Experimental | Procedure: robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection, Drug: 1.Abiraterone Acetate Tablets, Drug: Prednisone Acetate Tablets, Drug: Luteinizing Hormone-Releasing Hormone AnalogAfter 6 cycles of first-line treatment (Androgen deprivation therapy + abiraterone acetate along with prednisone) , patients will receive robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection (ePLND) within 9 months of being diagnosed. The ADT+abiraterone treatment will be maintained after surgery. |
| ADT plus abiraterone | Active comparator | Drug: 1.Abiraterone Acetate Tablets, Drug: Prednisone Acetate Tablets, Drug: Luteinizing Hormone-Releasing Hormone AnalogPatients will be only treated with Androgen deprivation therapy + abiraterone acetate along with prednisone. Prostatectomy won't be performed. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must be ≥ 40 and ≤75 years of age.
- All patients must have a histologically or cytologically diagnosis of prostate cancer.
- All patients must have been diagnosed oligometastatic prostate cancer which meet the following criteria. (1) ≤5 metastatic lesions are found by imaging examination (2)No visceral metastasis was found (3) The diameter of a single lesion ≤5cm or the surface area ≤250cm2.
- Patients previously treated with surgical castration or androgen deprivation therapy must maintain a testosterone level of <50ng/dl or <1.7nmol/L during treatment. Also the treatment duration should be less than 9 months. Patients were previously treated with at least 6 cycles of abiraterone.
- PSA<2ng/ml before enrollment.
Key exclusion criteria (10 listed)
- Patients with neuroendocrine, small cell, or signet ring cell histological features are not eligible.
- Patients with visceral metastasis or more than 5 metastatic lesions are excluded.
- Patients were diagnosed metastatic castration-naive prostate cancer for more than 9 months or showed biochemical or radiographic progression before enrollment.
- Patients with unresectable primary lesion before enrollment based on CT/MRI.
- Patients received local treatments such as pre-focal treatment, radiotherapy and palliative endoscopic resection.
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 |
|---|---|---|
| robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissectionRobot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed. | Procedure or surgery | ADT plus abiraterone + surgery |
| 1.Abiraterone Acetate Tablets1000mg(4 tablets, 250mg per tablet) daily for 6 cycles | Drug | ADT plus abiraterone, ADT plus abiraterone + surgery |
| Prednisone Acetate Tablets5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets | Drug | ADT plus abiraterone, ADT plus abiraterone + surgery |
| Luteinizing Hormone-Releasing Hormone AnalogHypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect. | Drug | ADT plus abiraterone, ADT plus abiraterone + surgery |
Primary outcome
Time to PSA progression progression
Time frame: up to 2 years
PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.
Time to Radiographic progression
Time frame: up to 2 years
Radiographic progression is defined as newly discovered soft tissue metastasis according to the RECIST 1.1 or at least 2 bone lesions.
4 secondary outcomes
rPFS (radiographic progression free survival)
Time frame: up to 2 years
Time to castration resistance
Time frame: up to 2 years
Time to PSA remission (≥50%) and time to PSA remission (≥90%)
Time frame: up to 2 years
Time to new anti-cancer treatment
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 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. This study is not recruiting at the moment.
Hongqian Guo, MD principal investigator
Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection, 1.Abiraterone Acetate Tablets and Prednisone Acetate Tablets in people with Prostatectomy and Oligometastatic Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 12 inclusion and 10 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: finished, as of the sponsor's last update on 5 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to PSA progression progression (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 Dec 2024.