Neoadjuvant Therapy \ High Risk Prostate Cancer \ DocetaxelPhase 2NCT04869371

Androgen Deprivation Therapy Combined With Docetaxel for High Risk Prostate Cancer

A Phase 2 study testing Docetaxel injection, Triptorelin Pamoate for Injectable Suspension and Prednisone Acetate Tablets in people with Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel, run by Hongqian Guo at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This randomized, controlled, single center clinical trial aims to evaluate the efficacy and safety of Androgen Deprivation Therapy Combined with Docetaxel for High Risk Prostate Cancer with a six-month treatment cycle. Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
What is being tested?: Docetaxel injection, Triptorelin Pamoate for Injectable Suspension and Prednisone Acetate Tablets
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteChina
Study dates: 12 Dec 2018to 1 Jan 2023
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 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must be ≥ 18 and ≤75 years of age.
All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
All patients must undergo thorough tumor staging and meet one of the following criteria:
multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T3,
Gleason score of primary tumor ≥ 8, 3.prostate specific antigen (PSA) ≥20 ng/ml.
Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.

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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 ≥ 9 g / 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 prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3, Gleason score of primary tumor < 8, and 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 are not eligible.
Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy 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.

China1 site

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer

Conditions: Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
Being tested: Docetaxel injection, Triptorelin Pamoate for Injectable Suspension, Prednisone Acetate Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Docetaxel injectionDrug
75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy
Triptorelin Pamoate for Injectable SuspensionDrug
15mg every 12 weeks
Prednisone Acetate TabletsDrug
5 mg oral low dose prednisone, once daily

Study groups in NCT04869371
Study group	Role	What they receive
Androgen Deprivation Therapy with Docetaxel	Experimental	All subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished. Receives: Drug: Docetaxel injection; Drug: Triptorelin Pamoate for Injectable Suspension; Drug: Prednisone Acetate Tablets
ADT alone	Active comparator	All subjects in this arm will receive LHRHa alone for 24 weeks before receiving robot assisted radical prostatectomy. Triptorelin Pamoate 15mg will be administered once per 12 weeks. Receives: Drug: Triptorelin Pamoate for Injectable Suspension

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 8 months
pCR or MRD rate
The proportion of patients with pCR or MRD. Pathologic complete response (pCR): defined as no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
Minimal Residual Disease (MRD): defined as residual tumors with maximum diameter of 3 mm or less after radical prostatectomy.
Measured: up to 8 months

Secondary outcomes (15)

Imaging Response Rate
The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm.
Measured: up to 8 months
Rate of Stage Degradation
Clinical or pathological stage degradation after neoadjuvant therapy
Measured: up to 8 months
Rate of Positive Surgical Margins
The proportion of subjects with positive surgical margins after radical prostatectomy.
Measured: up to 8 months
Rate of Complete Serum Remission
The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 6 months of treatment.
Measured: up to 8 months
Operative time (min)
The operative time(min) of radical prostatectomy.
Measured: 12 month
Estimated blood loss (ml)
Estimated blood loss (ml) during the process of radical prostatectomy.
Measured: 12 month
Hospital length of stay (day)
The hospitalization time, recorded in day.
Measured: 12 month
Drainage duration (day)
Length of drainage duration, recorded in day.
Measured: 12 month
Incidence of complications (%)
The proportion of subjects who suffer from major complications.
Measured: 12 month
Recovery time of urinary continence (day)
The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.
Measured: 12 month
biochemical progression-free survival (bPFS)
Biochemical progression was defined as two consecutive rising PSA values that were above 0.2ng/ml at least one month apart, or starting adjuvant therapy after surgery including radiotherapy, ADT or anti-androgen therapy. The time for bPFS was measured from randomization to biochemical progression or death from any cause.
Measured: 3 years
metastasis-free survival (MFS)
Time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.
Measured: 5 years
Serum complete response rate
Serum complete response rate, defined as the proportion of participants with PSA ≤ 0.1 ng/mL after 6-month neoadjuvant therapy.
Measured: after 6 month neoadjuvant therapy and before surgery
Rate of extracapsular extension
The proportion of patients with extracapsular extension on pathologic specimens after neoadjuvant therapy.
Measured: 12 month
Rate of positive lymph node
The proportion of patients with positive lymph node on pathologic specimens after neoadjuvant therapy.
Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 20181 Jan 2023

First posted3 May 2021
Study start12 Dec 2018
Primary completion1 Dec 2020
Study completion1 Jan 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neoadjuvant Therapy \ High Risk Prostate Cancer \ DocetaxelStudies 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
Masking: None (open label)
Enrolment: 75 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04869371
Sponsor's protocol ID: IUNU-PC-106
Status last verified: Dec 2022
First submitted: 9 Apr 2021
Last updated: 29 Dec 2022
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Zhuang J, Wang Y, Zhang S, Fu Y, Huang H, Lyu X, Zhang S, Marra G, Xu L, Qiu X, Guo H. Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials. Front Pharmacol. 2023 Jun 26;14:1217303. doi: 10.3389/fphar.2023.1217303. eCollection 2023.
PubMed 37435500

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer
ClinicalTrials.gov ID: NCT04869371
Acronym / sponsor ID: IUNU-PC-106
Conditions: Neoadjuvant Therapy \ High Risk Prostate Cancer \ Docetaxel
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 75 participants (estimated)
Lead sponsor: Hongqian GuoUniversity, hospital or other
Study start: 12 Dec 2018 (actual)
Primary completion: 1 Dec 2020 (actual)
Study completion: 1 Jan 2023 (estimated)
First posted: 3 May 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Androgen Deprivation Therapy with Docetaxel	Experimental	Drug: Docetaxel injection, Drug: Triptorelin Pamoate for Injectable Suspension, Drug: Prednisone Acetate TabletsAll subjects in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus docetaxel and prednisone, as per standard of care. Triptorelin pamoate (Diphereline) 15mg will be used once per 12 weeks. Docetaxel (75 mg/m2 body surface area) will be administered as intravenous drip every 3 weeks for 6 cycles. Robot assisted radical prostatectomy will be followed in 2 weeks when 24-week treatment cycle is finished.
ADT alone	Active comparator	Drug: Triptorelin Pamoate for Injectable SuspensionAll subjects in this arm will receive LHRHa alone for 24 weeks before receiving robot assisted radical prostatectomy. Triptorelin Pamoate 15mg will be administered once per 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients must be ≥ 18 and ≤75 years of age.
All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
All patients must undergo thorough tumor staging and meet one of the following criteria:
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.

Key exclusion criteria (9 listed)

Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible.
Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3, Gleason score of primary tumor < 8, and 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 are not eligible.
Patients who have previously received androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy 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
Docetaxel injection75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy	Drug	Androgen Deprivation Therapy with Docetaxel
Triptorelin Pamoate for Injectable Suspension15mg every 12 weeks	Drug	ADT alone, Androgen Deprivation Therapy with Docetaxel
Prednisone Acetate Tablets5 mg oral low dose prednisone, once daily	Drug	Androgen Deprivation Therapy with Docetaxel

Primary outcome

Pathologic Complete Response Rate
Time frame: up to 8 months
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy.
pCR or MRD rate
Time frame: up to 8 months
The proportion of patients with pCR or MRD. Pathologic complete response (pCR): defined as no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy. Minimal Residual Disease (MRD): defined as residual tumors with maximum diameter of 3 mm or less after radical prostatectomy.

15 secondary outcomes

Imaging Response Rate
Time frame: up to 8 months
Rate of Stage Degradation
Time frame: up to 8 months
Rate of Positive Surgical Margins
Time frame: up to 8 months
Rate of Complete Serum Remission
Time frame: up to 8 months
Operative time (min)
Time frame: 12 month
Estimated blood loss (ml)
Time frame: 12 month
Hospital length of stay (day)
Time frame: 12 month
Drainage duration (day)
Time frame: 12 month
Incidence of complications (%)
Time frame: 12 month
Recovery time of urinary continence (day)
Time frame: 12 month
biochemical progression-free survival (bPFS)
Time frame: 3 years
metastasis-free survival (MFS)
Time frame: 5 years
Serum complete response rate
Time frame: after 6 month neoadjuvant therapy and before surgery
Rate of extracapsular extension
Time frame: 12 month
Rate of positive lymph node
Time frame: 12 month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
Derived from this study: PubMed 37435500Zhuang J, Wang Y, Zhang S, Fu Y, Huang H, Lyu X, Zhang S, Marra G, Xu L, Qiu X, Guo H. Androgen deprivation therapy plus abiraterone or docetaxel as neoadjuvant therapy for very-high-risk prostate cancer: a pooled analysis of two phase II trials. Front Pharmacol. 2023 Jun 26;14:1217303. doi: 10.3389/fphar.2023.1217303. eCollection 2023.

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?

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 10 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 29 Dec 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?

Results are not available in the source record.

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?

Pathologic Complete Response Rate (time frame: up to 8 months). 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?

On the ClinicalTrials.gov record for NCT04869371, which also lists 1 linked publication.

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 29 Dec 2022.