Cohort StudiesEarly Phase 1NCT05713578

Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study

A Early Phase 1 study testing apantamide+docetaxel+ADT and apantamide+ADT treatment in people with Cohort Studies, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Cohort Studies
What is being tested?: apantamide+docetaxel+ADT and apantamide+ADT treatment
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteChina
Study dates: 1 Mar 2023to 1 Dec 2026
Phase: Early Phase 1
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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years, male;
It was diagnosed as prostate adenocarcinoma by histological or cytological examination, and its pathological type was adenocarcinoma;
Bone imaging, CT or MRI showed ≥ 4 bone metastases (≥ 1 bone metastasis located outside the pelvis or spine) or visceral metastasis;
.Patients with recurrence after new or local treatment are sensitive to endocrine therapy;
Patients receiving ADT treatment (drug or surgical castration), with or without the first generation of antiandrogen drugs, for no more than 3 months, and without evidence of soft tissue imaging disease progression (according to RECIST 1.1 standard) or clinically significant PSA increase (after serum testosterone reaches the castration level, PSA increases by 50% from the lowest level), are allowed to be included in the group;
Plan to receive docetaxel combined with apantamide and ADT or apantamide combined with ADT;

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ECOG PS score 0-1;
Adequate hematology and organ function:
Adequate bone marrow function (no blood transfusion, no use of granulocyte colony stimulating factor): absolute neutrophil count (ANC) ≥ 1.5 × 109/L（1500/ μ L）； Hemoglobin ≥ 90 g/L (9.0 g/dL); Platelet count ≥ 100 × 109/L（100, 000/ μ L）；
Adequate liver function: total bilirubin (TBIL) ≤ 1.5 × ULN； AST, ALT and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal value (ULN);
Adequate renal function: serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min (calculated using Cockcroft Gault formula);
Sufficient coagulation function (without anticoagulation treatment): International normalized ratio (INR) ≤ 1.5;

Who cannot join

Have a history of hypersensitivity or intolerance to any drug used in the study;
Plan to receive any other anti-tumor treatment during the study period;
Patients who have received the second generation of androgen receptor (AR) inhibitors in the past, such as apantamide, enzalutamide, darotamide (ODM-201) or other AR inhibitors, CYP17 enzyme inhibitors, such as abietron acetate or oral ketoconazole, chemotherapy or immunotherapy, as well as adjuvant or new adjuvant therapy, should also be excluded;
Four weeks before the start of the study, he received plant drugs (such as saw palmetto) that have the effect of anti prostate cancer or reducing PSA level;
Have a history of epileptic seizures, a history of medication that can reduce the threshold of epileptic seizures, or a disease that can induce epileptic seizures within 12 months before the start of the study and treatment (including a history of transient ischemic attacks, cerebral apoplexy, brain trauma and disturbance of consciousness requiring hospitalization);
There were active heart diseases within 6 months before the start of study treatment, including severe/unstable angina, myocardial infarction, congestive heart failure [NYHA III or IV], or arrhythmias requiring drug treatment;

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There is inability to swallow, chronic diarrhea, intestinal obstruction or other factors affecting drug administration and absorption;
Have a history of immunodeficiency (including HIV test positive, other acquired and congenital immunodeficiency diseases) or organ transplantation;
Known brain metastasis;
Malignant tumors other than prostate cancer in the past 5 years or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
Those who are receiving any other experimental drugs or experimental medical devices;
Poor compliance, difficult to cooperate with treatment and follow-up;
The investigator believes that the patient has concomitant diseases (such as poorly controlled hypertension, serious diabetes, neurological or mental diseases, etc.) that seriously endanger the patient's safety, may confuse the research results, or affect the patient to complete the study, or any other situation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Benkang Shi, Dr. contact

18560083917

bkang68@sdu.edu.cn

China1 site, 1 recruiting

Qilu hospital
Jinan, Shandong, 276600
Benkang Shi, bkang68@sdu.edu.cn, bkang68@sdu.edu.cn
Recruiting

Other trials in China

About this study

This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two treatment groups according to the treatment plan:Treatment group 1: apantamide+docetaxel+ADT,Treatment group 2: apantamide+ADT treatment.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Read the detailed description

Treatment group 1: apantamide+docetaxel+ADT

Patients were treated with apantamide+docetaxel+ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions).Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator;The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles. It is up to the researcher to decide whether to use prednisone or prednisolone. To prevent docetaxel related hypersensitivity and fluid retention, oral administration of 8 mg dexamethasone is recommended 12 hours, 3 hours and 1 hour before infusion of docetaxel.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Treatment group 2: apantamide+ADT treatment

Patients were treated with apantamide and ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions)Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT used in each research center are determined by the investigator.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.

Conditions: Cohort Studies
Being tested: apantamide+docetaxel+ADT, apantamide+ADT treatment
Keywords: cohort study, apantamide, docetaxel, ADT

What participants receive

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

apantamide+docetaxel+ADTDrug
Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator; The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.
apantamide+ADT treatmentDrug
apantamide+ADT treatment

Study groups in NCT05713578
Study group	Role	What they receive
apantamide+docetaxel+ADT	Experimental	The dosage is adjusted according to the adverse reaction (according to the instructions).Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator;The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles. It is up to the researcher to decide whether to use prednisone or prednisolone. Receives: Drug: apantamide+docetaxel+ADT
apantamide+ADT treatment	Active comparator	Patients were treated with apantamide and ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions)Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT used in each research center are determined by the investigator. Receives: Drug: apantamide+ADT treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

3-year radiographic progression free survival (rPFS) rate
RPFS is defined as the time from the start of study treatment to the occurrence of imaging progress or death due to any reason, whichever occurs first.（%）
Measured: 3 years

Secondary outcomes (3)

Time to CRPC
Time to CRPC（months）
Measured: 36 months
To PSA progress time;
Time to PSA progress（months）
Measured: 36 months
Asymptomatic skeletal event (SSE) survival;
Asymptomatic skeletal event (SSE) survival.（%）
Measured: 36 months

Timeline

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

1 Mar 20231 Dec 2026

First posted6 Feb 2023
Study start1 Mar 2023 (estimated)
Primary completion1 Feb 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cohort StudiesStudies of the same condition, open and under way.
More trials run by Qilu Hospital of Shandong UniversityThe 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: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Experimental: apantamide+docetaxel+ADT;Active.Comparator: apantamide+ADT treatment
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05713578
Sponsor's protocol ID: bks01
Status last verified: Jan 2023
First submitted: 2 Jan 2023
Last updated: 6 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Benkang Shi, Dr.

18560083917

bkang68@sdu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study
ClinicalTrials.gov ID: NCT05713578
Acronym / sponsor ID: bks01
Conditions: Cohort Studies
Keywords: cohort study, apantamide, docetaxel, ADT
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 220 participants (estimated)
Lead sponsor: Qilu Hospital of Shandong UniversityUniversity, hospital or other
Study start: 1 Mar 2023 (estimated)
Primary completion: 1 Feb 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 6 Feb 2023 (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.

Detailed description

Treatment group 1: apantamide+docetaxel+ADT

Treatment group 2: apantamide+ADT treatment

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: Experimental: apantamide+docetaxel+ADT;Active.Comparator: apantamide+ADT treatment

Arm	Type	Receives
apantamide+docetaxel+ADT	Experimental	Drug: apantamide+docetaxel+ADTThe dosage is adjusted according to the adverse reaction (according to the instructions).Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator;The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles. It is up to the researcher to decide whether to use prednisone or prednisolone.
apantamide+ADT treatment	Active comparator	Drug: apantamide+ADT treatmentPatients were treated with apantamide and ADT after enrollment. The patient received each drug treatment according to the instructions. The dosage is adjusted according to the adverse reaction (according to the instructions)Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally;ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT used in each research center are determined by the investigator.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Age ≥ 18 years, male;
It was diagnosed as prostate adenocarcinoma by histological or cytological examination, and its pathological type was adenocarcinoma;
Bone imaging, CT or MRI showed ≥ 4 bone metastases (≥ 1 bone metastasis located outside the pelvis or spine) or visceral metastasis;
.Patients with recurrence after new or local treatment are sensitive to endocrine therapy;
Patients receiving ADT treatment (drug or surgical castration), with or without the first generation of antiandrogen drugs, for no more than 3 months, and without evidence of soft tissue imaging disease progression (according to RECIST 1.1 standard) or clinically significant PSA increase (after serum testosterone reaches the castration level, PSA increases by 50% from the lowest level), are allowed to be included in the group;

Key exclusion criteria (13 listed)

Have a history of hypersensitivity or intolerance to any drug used in the study;
Plan to receive any other anti-tumor treatment during the study period;
Patients who have received the second generation of androgen receptor (AR) inhibitors in the past, such as apantamide, enzalutamide, darotamide (ODM-201) or other AR inhibitors, CYP17 enzyme inhibitors, such as abietron acetate or oral ketoconazole, chemotherapy or immunotherapy, as well as adjuvant or new adjuvant therapy, should also be excluded;
Four weeks before the start of the study, he received plant drugs (such as saw palmetto) that have the effect of anti prostate cancer or reducing PSA level;
Have a history of epileptic seizures, a history of medication that can reduce the threshold of epileptic seizures, or a disease that can induce epileptic seizures within 12 months before the start of the study and treatment (including a history of transient ischemic attacks, cerebral apoplexy, brain trauma and disturbance of consciousness requiring hospitalization);

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
apantamide+docetaxel+ADTApantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator; The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.	Drug	apantamide+docetaxel+ADT
apantamide+ADT treatmentapantamide+ADT treatment	Drug	apantamide+ADT treatment

Primary outcome

3-year radiographic progression free survival (rPFS) rate
Time frame: 3 years
RPFS is defined as the time from the start of study treatment to the occurrence of imaging progress or death due to any reason, whichever occurs first.（%）

3 secondary outcomes

Time to CRPC
Time frame: 36 months
To PSA progress time;
Time frame: 36 months
Asymptomatic skeletal event (SSE) survival;
Time frame: 36 months

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 6 Feb 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.

Benkang Shi, Dr. contact

18560083917

bkang68@sdu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing apantamide+docetaxel+ADT and apantamide+ADT treatment in people with Cohort Studies, run by Qilu Hospital of Shandong University 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 13 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 6 Feb 2023. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Contact Benkang Shi, Dr. (18560083917, bkang68@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year radiographic progression free survival (rPFS) rate (time frame: 3 years). 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 NCT05713578.

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 6 Feb 2023.