Neoadjuvant TherapyPhase 2NCT05406999
Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
A Phase 2 study testing ADT, Abiraterone Acetate and Prednisolone tablets in people with Neoadjuvant Therapy and High Risk Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Neoadjuvant Therapy, High Risk Prostate Cancer, Locally Advanced Prostate Cancer
- What is being tested?
- ADT, Abiraterone Acetate and Prednisolone tablets
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 Jun 2030
- Phase
- Phase 2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
- All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1).
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
- Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
- 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 bewilling to obey the prohibitions and restrictions specified in the research protocol.
- Fertile patients must be willing to use highly effective contraception during the study period and within 120 days of the last dose of treatment.
Who cannot join
- Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
- Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3; b) Gleason score of primary tumor < 8; c) prostate specific antigen (PSA) <20 ng/ml.
- Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.
- Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.
- Patients with severe or uncontrolled concurrent infections are not eligible.
- 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.
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- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- 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
About this study
Official title: A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
Read the detailed description
The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.
- Conditions
- Neoadjuvant Therapy, High Risk Prostate Cancer, Locally Advanced Prostate Cancer, Intense Endocrine Therapy
- Being tested
- ADT, Abiraterone Acetate, Prednisolone tablets, Enzalutamide, Apalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADTDrug
The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect.
Abiraterone AcetateDrug
1000 mg (250 mg×4 tablets) once daily, orally
Prednisolone tabletsDrug
5 mg once daily, orally.
EnzalutamideDrug
160 mg (40 mg× 4 tablets) once daily, orally.
ApalutamideDrug
240 mg (60 mg×4 tablets) once daily, orally.
DarotamideDrug
600 mg (300 mg × 2 tablets) twice daily, orally.
RezvilutamideDrug
240 mg (80 mg × 3 tablets) once daily orally
PARP inhibitorDrug
The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.
Robot-assisted radical prostatectomyProcedure or surgery
Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| ADT alone + prostatectomy | Active comparator | A total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Procedure: Robot-assisted radical prostatectomy |
| ADT plus Abiraterone | Experimental | A total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Drug: Abiraterone Acetate; Drug: Prednisolone tablets; Procedure: Robot-assisted radical prostatectomy |
| ADT plus Enzalutamide | Experimental | A total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Drug: Enzalutamide; Procedure: Robot-assisted radical prostatectomy |
| ADT plus Apalutamide | Experimental | A total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Drug: Apalutamide; Procedure: Robot-assisted radical prostatectomy |
| ADT plus Darotamide | Experimental | A total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Drug: Darotamide; Procedure: Robot-assisted radical prostatectomy |
| ADT plus Rizvilutamide | Experimental | A total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Drug: Rezvilutamide; Procedure: Robot-assisted radical prostatectomy |
| PARP inhibitor + abiraterone + ADT | Experimental | A total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Drug: Abiraterone Acetate; Drug: Prednisolone tablets; Drug: PARP inhibitor; Procedure: Robot-assisted radical prostatectomy |
| PARP inhibitor + ADT | Experimental | A total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. Receives: Drug: ADT; Drug: PARP inhibitor; Procedure: Robot-assisted radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response rate
Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate
Measured: up to 3 years
3 year biochemical progression free survival (bPFS)
Biochemical progression free survival (bPFS) within 3 years
Measured: up to 3 years
Secondary outcomes (6)
Metastasis-Free Survival (MFS)
Metastasis-Free Survival (MFS) after intense neoadjuvant therapy
Measured: up to 5 years
Time to castration-resistant prostate cancer（CRPC)
Time to castration-resistant prostate cancer（CRPC) after intense neoadjuvant therapy
Measured: up to 5 years
PSA response rate
Prostate specific antigen (PSA) drops ≥ 98% after intense neoadjuvant therapy
Measured: up to 3 years
Positive margin rate
The positive margin rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy
Measured: up to 6 months
Pathologic downgrade rate
The pathologic downgrade rate of whole-mount pathology for prostatectomy after intense neoadjuvant therapy compared with initial T stage.
Measured: up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. All grades of adverse events will be documented.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Feb 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2030 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406999
- Sponsor's protocol ID
- IUNU-PC-118
- Status last verified
- Aug 2022
- First submitted
- 29 May 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT05406999
- Acronym / sponsor ID
- IUNU-PC-118
- Conditions
- Neoadjuvant Therapy, High Risk Prostate Cancer, Locally Advanced Prostate Cancer, Intense Endocrine Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 7 Jun 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.
This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
Detailed description
The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ADT alone + prostatectomy | Active comparator | Drug: ADT, Procedure: Robot-assisted radical prostatectomyA total of 100 subjects receive ADT for 6 cycles (28 days per cycle) before prostatectomy. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
| ADT plus Abiraterone | Experimental | Drug: ADT, Drug: Abiraterone Acetate, Drug: Prednisolone tablets, Procedure: Robot-assisted radical prostatectomyA total of 150 subjects in this group received abiraterone acetate + prednisolone acetate daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
| ADT plus Enzalutamide | Experimental | Drug: ADT, Drug: Enzalutamide, Procedure: Robot-assisted radical prostatectomyA total of 50 subjects in this group received enzalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
| ADT plus Apalutamide | Experimental | Drug: ADT, Drug: Apalutamide, Procedure: Robot-assisted radical prostatectomyA total of 150 subjects in this group received apalutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
| ADT plus Darotamide | Experimental | Drug: ADT, Drug: Darotamide, Procedure: Robot-assisted radical prostatectomyA total of 150 subjects in this group received darotamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
| ADT plus Rizvilutamide | Experimental | Drug: ADT, Drug: Rezvilutamide, Procedure: Robot-assisted radical prostatectomyA total of 150 subjects in this group received rizvilutamide daily for 6 cycles along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
| PARP inhibitor + abiraterone + ADT | Experimental | Drug: ADT, Drug: Abiraterone Acetate, Drug: Prednisolone tablets, Drug: PARP inhibitor, Procedure: Robot-assisted radical prostatectomyA total of 100 subjects in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor plus abiraterone along with ADT. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
| PARP inhibitor + ADT | Experimental | Drug: ADT, Drug: PARP inhibitor, Procedure: Robot-assisted radical prostatectomyA total of 50 subjects in this group in this group received Poly ADP-ribose Polymerase (PARP) Inhibitor along with ADT mentioned above. Enrolled patients carry homologous recombination repair (HRR) gene mutation verified by molecular testing. Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients must have been histologically diagnosed of prostate cancer and must be eligible for radical prostatectomy.
- All patients must undergo thorough tumor staging and meet one of the following criteria: a) multi-parameter MRI or PSMA PET/CT shows clinical staging of primary tumor ≥ T3; b) Gleason score of primary tumor ≥ 8; c)prostate specific antigen(PSA) ≥20 ng/ml; d) Imaging evaluation shows regional lymph node metastases (N1).
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
- Patients must have adequate hematologic function, hepatic function, renal function and cardiac function.
- 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 bewilling to obey the prohibitions and restrictions specified in the research protocol.
Key exclusion criteria (9 listed)
- Patients with neuroendocrine, small cell, or sarcoma-like pathologic features are not eligible.
- Patients with low-risk or medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: a) multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3; b) Gleason score of primary tumor < 8; c) prostate specific antigen (PSA) <20 ng/ml.
- Patients with clinical or radiological evidence of extra-regional lymph node metastases or bone metastases or visceral metastases (any M1) are not eligible.
- Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment, radiotherapy, chemotherapy for prostate cancer are not eligible.
- Patients with severe or uncontrolled concurrent infections are not eligible.
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 |
|---|---|---|
| ADTThe ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect. | Drug | ADT alone + prostatectomy, ADT plus Abiraterone, ADT plus Apalutamide, ADT plus Darotamide, ADT plus Enzalutamide, ADT plus Rizvilutamide, PARP inhibitor + ADT, PARP inhibitor + abiraterone + ADT |
| Abiraterone Acetate1000 mg (250 mg×4 tablets) once daily, orally | Drug | ADT plus Abiraterone, PARP inhibitor + abiraterone + ADT |
| Prednisolone tablets5 mg once daily, orally. | Drug | ADT plus Abiraterone, PARP inhibitor + abiraterone + ADT |
| Enzalutamide160 mg (40 mg× 4 tablets) once daily, orally. | Drug | ADT plus Enzalutamide |
| Apalutamide240 mg (60 mg×4 tablets) once daily, orally. | Drug | ADT plus Apalutamide |
| Darotamide600 mg (300 mg × 2 tablets) twice daily, orally. | Drug | ADT plus Darotamide |
| Rezvilutamide240 mg (80 mg × 3 tablets) once daily orally | Drug | ADT plus Rizvilutamide |
| PARP inhibitorThe PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect. | Drug | PARP inhibitor + ADT, PARP inhibitor + abiraterone + ADT |
| Robot-assisted radical prostatectomyRobot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy. | Procedure or surgery | ADT alone + prostatectomy, ADT plus Abiraterone, ADT plus Apalutamide, ADT plus Darotamide, ADT plus Enzalutamide, ADT plus Rizvilutamide, PARP inhibitor + ADT, PARP inhibitor + abiraterone + ADT |
Primary outcome
Pathologic response rate
Time frame: up to 3 years
Pathologic response rate= Pathologic Complete Response (pCR) Rate + Minimal Residual Disease (MRD) rate
3 year biochemical progression free survival (bPFS)
Time frame: up to 3 years
Biochemical progression free survival (bPFS) within 3 years
6 secondary outcomes
Metastasis-Free Survival (MFS)
Time frame: up to 5 years
Time to castration-resistant prostate cancer（CRPC)
Time frame: up to 5 years
PSA response rate
Time frame: up to 3 years
Positive margin rate
Time frame: up to 6 months
Pathologic downgrade rate
Time frame: up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 5 years
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 16 Aug 2022.
- 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.
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, China
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 ADT, Abiraterone Acetate and Prednisolone tablets in people with Neoadjuvant Therapy and High Risk 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 6 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: looking for participants now, as of the sponsor's last update on 16 Aug 2022. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response rate (time frame: up to 3 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 16 Aug 2022.