Neoadjuvant TherapyPhase 2NCT05376722
A Study of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of Prostate Cancer
A Phase 2 study testing pamiparib, abiraterone and prednisone in people with Neoadjuvant Therapy, run by Hongqian Guo at 3 sites in China.
Trial summary
To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Neoadjuvant Therapy
- What is being tested?
- pamiparib, abiraterone and prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 22 Feb 2022to Sep 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged ≥18 years and ≤80 years old.
- Patients with prostate cancer diagnosed by histology or cytology who are suitable for radical prostatectomy.
- All patients meet at least one of the following criteria:
- Multiparametric MRI and PSMA PET/CT scan or CT scan showing primary tumor stage ≥ T3;
- Primary tumor Gleason score ≥ 8;
- Serum PSA concentration ≥ 20 ng/ml;
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- Imaging assessment has regional lymph node metastasis (N1);
- Eastern Cooperative Oncology Group (ECOG) performance status score≤1
- Laboratory inspections meet the following requirements:
- Blood routine: white blood cell count (WBC) ≥3.0×109/L, platelet count ≥100×109/L, hemoglobin ≥9g/dl; renal function: serum creatinine ≤2×ULN; liver function: alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, total bilirubin TBIL≤1.5×ULN; coagulation function: international normalized ratio (INR)<1.5.
- The subjects participate voluntarily, and the subjects themselves must sign the Informed Consent Form (ICF), indicating that they understand the purpose and required procedures of this research, and are willing to participate in the research. Subjects must be willing and comply with the prohibitions and restrictions set forth in the study protocol.
- During the treatment, the testosterone level in the blood is reduced to the "castration" level, and the testosterone level is less than 50ng/dL;
- The subjects can understand and are willing to sign the informed consent
Who cannot join
- Patients with neuroendocrine, small cell, or sarcomatoid features on prostate histopathology.
- Low- and intermediate-risk localized prostate cancer (all the following conditions are met) (PSA<20 ng/mL; Gleason score<8; clinical stage<T3).
- Patients with clinical or radiological evidence suggestive of extraregional lymph node metastasis or bone or visceral metastasis (any M1).
- Received androgen deprivation therapy (including drug or surgical castration) for more than 3 months or focal prostate cancer treatment or prostate cancer radiotherapy and chemotherapy in the past.
- Patients with severe or uncontrolled concurrent infections.
- Suffering from New York Heart Association (NYHA) class III/IV congestive heart failure, unstable angina or a history of myocardial infarction within the past 6 months.
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- Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- In the past 5 years, other malignancies other than prostate cancer, but cured basal or squamous cell skin cancer can be enrolled.
- Suffering from mental illness, mental disability or inability to give informed consent.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210000
Shun Zhang, 15050589789 ext. 15050589789, explorershun@126.com
- Recruiting
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210000
Junlong Zhuang, MD, 8615950451917, zhuangjl-2008@163.com
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Hongqian Guo, Phd, 8613605171690, dr.ghq@nju.edu.cn
Shun Zhang, MD, 8615050589789, explorershun@126.com
About this study
Official title: A Prospective Clinical Study of the Safety and Efficacy of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of High-risk or Very High-risk Localized Prostate Cancer
To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
Read the detailed description
the main purpose: To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant treatment of surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy; Note: pathological response rate = pathological complete response rate (pCR) + minimal residual disease (MRD)(defined as residual tumor with the largest crosssection dimension ≤5 mm OR RCB≤0.25CM³)
Secondary purpose:
- To evaluate the safety of pamiparib combined with abiraterone acetate as neoadjuvant therapy for high-risk or very high-risk prostate cancer;
- To evaluate the rate of PSA biochemical recurrence-free survival (bPFS) at 1 year after radical prostatectomy in neoadjuvant treatment of high-risk or very-high-risk prostate cancer with pamiparib combined with abiraterone acetate;
- The positive rate of surgical margins in radical prostatectomy;
- Downstaging rate of radical prostatectomy;
- Pathological response rate of neoadjuvant patients with HRR gene mutation;
- Conditions
- Neoadjuvant Therapy
- Being tested
- pamiparib, abiraterone, prednisone
- Keywords
- pamiparib, abiraterone acetate, high-risk prostate cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pamiparibDrug
pamiparib 40 mg orally, twice a day
abirateroneDrug
biraterone acetate 1000 mg orally, once a day
prednisoneDrug
prednisone acetate tablets (prednisone) 5 mg, once a day
| Study group | Role | What they receive |
|---|---|---|
| pamiparib | Experimental | Subjects received pamiparib 40 mg orally, twice a day; abiraterone acetate 1000 mg orally, once a day; prednisone acetate tablets (prednisone) 5 mg, once a day; every 30 days Treatment cycle, treatment for 4-6 cycles, that is, 4-6 months. Robot-assisted laparoscopic radical prostatectomy and extended lymph node dissection within 30 days of the end of 4 months of neoadjuvant therapy. If the subjects have intolerable toxic reactions during the treatment period, the dose adjustment can be carried out. Day 1 of cycle 1, day 15 and day 1±3 days of each cycle thereafter, and 1 follow-up within 30 days after the end of treatment and before surgery; 1 prostate MRI during the screening period and within 30 days after the end of treatment and before surgery Scan, PSMA PET/CT scan or CT scan Receives: Drug: pamiparib; Drug: abiraterone; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
Measured: up to 6months
Secondary outcomes (6)
AEs/SAEs
The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug.
The level of complications defined by Clavien-Dindo classification.
Measured: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
the 1-year PSA biochemical recurrence-free survival (bPFS) rate after radical prostatectomy in neoadjuvant therapy of paamiparib combined with abiraterone acetate in high- or very-high-risk prostate cancer
Defined as the proportion of patients who did not experience biochemical progression or death within 3 years of initiation of pamiparib treatment; biochemical progression was defined as an increase in serum PSA level to >0.2 ng/ml with 2 consecutive increases at least 3 months apart
Measured: 3 years
Rate of Positive Surgical Margins
The proportion of subjects with positive surgical margins after radical prostatectomy
Measured: up to 8 months
Downstaging rate of radical prostatectomy
Downstaging rate of radical prostatectomy
Measured: four months to 2 years after surgery
Pathological response rate of neoadjuvant patients with HRR gene mutation
Pathological response rate of neoadjuvant patients with HRR gene mutation
Measured: four months to 2 years after surgery
PSA response rate
The proportion of subjects with a ≥98% reduction in nadir PSA from baseline PSA during neoadjuvant therapy
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 posted17 May 2022
- Study start22 Feb 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongqian Guo
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Soochow University, Nanjing First Hospital, Nanjing Medical University
- Responsible party
- Sponsor-investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- shun zhang, Dr., Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376722
- Sponsor's protocol ID
- IUNU-PC-111
- Status last verified
- Oct 2022
- First submitted
- 23 Feb 2022
- Last updated
- 5 Jan 2023
- 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 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of the Safety and Efficacy of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of High-risk or Very High-risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT05376722
- Acronym / sponsor ID
- IUNU-PC-111
- Conditions
- Neoadjuvant Therapy
- Keywords
- pamiparib, abiraterone acetate, high-risk prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hongqian GuoUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Soochow University, Nanjing First Hospital, Nanjing Medical University
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 17 May 2022 (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 pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
Detailed description
the main purpose: To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant treatment of surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy; Note: pathological response rate = pathological complete response rate (pCR) + minimal residual disease (MRD)(defined as residual tumor with the largest crosssection dimension ≤5 mm OR RCB≤0.25CM³)
Secondary purpose:
- To evaluate the safety of pamiparib combined with abiraterone acetate as neoadjuvant therapy for high-risk or very high-risk prostate cancer;
- To evaluate the rate of PSA biochemical recurrence-free survival (bPFS) at 1 year after radical prostatectomy in neoadjuvant treatment of high-risk or very-high-risk prostate cancer with pamiparib combined with abiraterone acetate;
- The positive rate of surgical margins in radical prostatectomy;
- Downstaging rate of radical prostatectomy;
- Pathological response rate of neoadjuvant patients with HRR gene mutation;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pamiparib | Experimental | Drug: pamiparib, Drug: abiraterone, Drug: prednisoneSubjects received pamiparib 40 mg orally, twice a day; abiraterone acetate 1000 mg orally, once a day; prednisone acetate tablets (prednisone) 5 mg, once a day; every 30 days Treatment cycle, treatment for 4-6 cycles, that is, 4-6 months. Robot-assisted laparoscopic radical prostatectomy and extended lymph node dissection within 30 days of the end of 4 months of neoadjuvant therapy. If the subjects have intolerable toxic reactions during the treatment period, the dose adjustment can be carried out. Day 1 of cycle 1, day 15 and day 1±3 days of each cycle thereafter, and 1 follow-up within 30 days after the end of treatment and before surgery; 1 prostate MRI during the screening period and within 30 days after the end of treatment and before surgery Scan, PSMA PET/CT scan or CT scan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Blood routine: white blood cell count (WBC) ≥3.0×109/L, platelet count ≥100×109/L, hemoglobin ≥9g/dl; renal function: serum creatinine ≤2×ULN; liver function: alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, total bilirubin TBIL≤1.5×ULN; coagulation function: international normalized ratio (INR)<1.5.
Key exclusion criteria (9 listed)
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 |
|---|---|---|
| pamiparibpamiparib 40 mg orally, twice a day | Drug | pamiparib |
| abirateronebiraterone acetate 1000 mg orally, once a day | Drug | pamiparib |
| prednisoneprednisone acetate tablets (prednisone) 5 mg, once a day | Drug | pamiparib |
Primary outcome
the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
Time frame: up to 6months
To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
6 secondary outcomes
AEs/SAEs
Time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
the 1-year PSA biochemical recurrence-free survival (bPFS) rate after radical prostatectomy in neoadjuvant therapy of paamiparib combined with abiraterone acetate in high- or very-high-risk prostate cancer
Time frame: 3 years
Rate of Positive Surgical Margins
Time frame: up to 8 months
Downstaging rate of radical prostatectomy
Time frame: four months to 2 years after surgery
Pathological response rate of neoadjuvant patients with HRR gene mutation
Time frame: four months to 2 years after surgery
PSA response rate
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- 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.
shun zhang, Dr. principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pamiparib, abiraterone and prednisone in people with Neoadjuvant Therapy, run by Hongqian Guo at 3 sites 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 13 inclusion and 9 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hongqian guo, Dr. (13605171690, dr.ghq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy (time frame: up to 6months). 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 Jan 2023.