Neoadjuvant Therapy \High Risk Prostate CancerPhase 2NCT05076851
Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
A Phase 2 study testing Proxalutamide in people with Neoadjuvant Therapy \High Risk Prostate Cancer, run by Hongqian Guo at 1 site in China.
Trial summary
This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months, Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Neoadjuvant Therapy \High Risk Prostate Cancer
- What is being tested?
- Proxalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2021to 31 Oct 2022
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
- Patients must be ≥ 18，male
- Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
- High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
- Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
- ECOG PS：0-1
Who cannot join
- Imaging or biopsy confirmed distant Metastatic lesion
- The number of regional lymph nodes metastasis >3
- Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
- Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Shun zhang, Doctor, 15050589789, explorershun@126.com
Junlong Zhuang, Doctor, 15950451917, zhuangjl-2008@163.com
About this study
Official title: A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,
- Being tested
- placebo, Proxalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
placebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
ProxalutamideDrug
Proxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | placebo+ADT Receives: Other: placebo |
| Proxalutamide | Experimental | Proxalutamide +ADT Receives: Drug: Proxalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy
Measured: up to 6months
Proportion of Subjects With Minimal Residual Disease
The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy
Measured: up to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start17 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant Therapy \High Risk Prostate CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Proxalutamide: androgen deprivation therapy（ADT）=2:1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongqian Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Hongqian Guo, Phd, Study chair, Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076851
- Sponsor's protocol ID
- IIT-GT0918-CN-1008
- Status last verified
- Oct 2021
- First submitted
- 22 Jun 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05076851
- Acronym / sponsor ID
- IIT-GT0918-CN-1008
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Hongqian GuoUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 13 Oct 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 trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Proxalutamide: androgen deprivation therapy（ADT）=2:1
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Other: placeboplacebo+ADT |
| Proxalutamide | Experimental | Drug: ProxalutamideProxalutamide +ADT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
- Patients must be ≥ 18，male
- Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
- High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
- Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
Key exclusion criteria (4 listed)
- Imaging or biopsy confirmed distant Metastatic lesion
- The number of regional lymph nodes metastasis >3
- Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
- Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy
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 |
|---|---|---|
| placeboplacebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD | Other | placebo group |
| ProxalutamideProxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD | Drug | Proxalutamide |
Primary outcome
Pathologic Complete Response Rate
Time frame: up to 6months
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy
Proportion of Subjects With Minimal Residual Disease
Time frame: up to 6months
The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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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, Phd study chair
Study Chair Department of Urology, Drum Tower Hospital, 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 Proxalutamide in people with Neoadjuvant Therapy \High Risk Prostate Cancer, run by Hongqian Guo 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 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 13 Oct 2021. 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. Some participants in this study may receive a placebo. 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, Phd (+86-13605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response Rate (time frame: up to 6months). 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 13 Oct 2021.