Prostate CancerPhase 2NCT03356444

Docetaxel Versus Abiraterone as First-line Treatment in mCRPC Patients With Intraductal Carcinoma of the Prostate

A Phase 2 study testing Abiraterone Acetate and Docetaxel in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by West China Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Metastatic castration-resistant Prostate cancer (mCRPC) is a very late stage of prostate cancer with poor prognosis. Although there are several treatment strategies available for mCRPC, these drugs are not always effective for every patient. Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Prostate Cancer, Castration-resistant Prostate Cancer, Drug
What is being tested?: Abiraterone Acetate and Docetaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: No sites listed yet
Study dates: Nov 2017to Dec 2020
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 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: ≥40 years old
Positive IDC-P status confirmed by pathological examination.
Bone or visceral metastatic disease confirmed by image examination.
Castration resistant confirmed according to the criteria of 2014 EAU guidelines.
The ECOG score of the patient is ≤1
Expected survival over 3 months

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Blood routine test: neutrophil ≥1.5 × 10^9, platelets >100 × 10^9 and hemoglobin ≥90g/L
Blood biochemical indexes: bilirubin≤1.5×Upper limit of normal; AST≤2.5×Upper limit of normal; serum creatinine≤1.5×Upper limit of normal; serum calcium≤12.0mg/dL.
Coagulation function: Prothrombin time ≤1.5×Upper limit of normal
The following diseases were not found within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.
All patients should sign informed consent.

Who cannot join

Patients who had other types of cancer besides prostate cancer were excluded.
Patients With non-acinar adenocarcinoma except intraductal carcinoma of the prostate, including ductal adenocarcinoma, neuroendocrine carcinoma or small cell carcinoma of the prostate.
Prior chemotherapy or abiraterone for the treatment of mCRPC.
Patients with renal decompensation requiring hemodialysis or peritoneal dialysis.
Patients with severe active clinical infection
Patients with coagulopathy or bleeding

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Patients who received major surgery or severe trauma within the first 4 weeks before admission.
Patients with a history of allogeneic organ transplantation or bone marrow transplantation
Patients with known or suspected allergy to research drugs.

About this study

Official title: The Evaluation of First-line Treatment Efficacy of Docetaxel and Abiraterone in Metastatic Castration-resistant Prostate Cancer Patients With Intraductal Carcinoma of the Prostate and the Exploration of the Genes Related to Treatment Effect

In the previous works of the investigators, a subtype of prostate cancer, intraductal carcinoma of the prostate (IDC-P) was studied. The investigators have reported in their two published papers that, IDC-P is an adverse pathological type associated with rapid disease progression. They also found in another study that, for patients with IDC-P, Abiraterone seemed to have better treatment efficacy than Docetaxel-based chemotherapy as first-line treatment for mCRPC, in terms of either PSA-response and PSA-progression free survival. So, in this study, the investigators hope to design a prospective study to verify the predictive ability of IDC-P in the first-line treatment of mCRPC.

With disease progression, the drug resistance will inevitably occur in all patients after the treatment of CRPC. However, the exact mechanism of this process is not yet known. So, in this study the investigators are also trying to explore some of the genes related to the treatment efficacy by means of the next generation sequencing.

Conditions: Prostate Cancer, Castration-resistant Prostate Cancer, Drug
Being tested: Abiraterone Acetate, Docetaxel
Keywords: abiraterone, docetaxel, Castration-resistant Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

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

Abiraterone AcetateDrug
Abiraterone Acetate: orally, 1000mg, qd, plus with prednisone orally, 5mg, bid. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs.
DocetaxelDrug
Docetaxel: intravenously, 75 mg/m^2, over 1 h every 3 weeks, plus with prednisone, orally, 10 mg, qd.
Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs. If no progression, stop until 10 cycles of traetment

Study groups in NCT03356444
Study group	Role	What they receive
Abiraterone group	Experimental	Abiraterone acetate is administered in this arm. Receives: Drug: Abiraterone Acetate
Docetaxel group	Active comparator	Docetaxel is administered in this arm. Receives: Drug: Docetaxel

What is being measured

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

PSA-Progression free survival (PSA-PFS)
PSA progression was defined as an increase in the PSA level of 25% or more above the nadir (and by ≥ 2 ng/ml), with confirmation of 4 or more weeks later.
Measured: Up to 40 months
Radiographic progression free survival (rPFS)
rPFS was defined 1) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria; or 2) as at least two new lesions on first post-treatment bone scan, with at least two additional lesions on the next bone scan.
Measured: Up to 40 months

Secondary outcomes (3)

PSA response rate
PSA response is defined as ≥ 50% decline in PSA level from baseline, maintained for≥ 4 weeks
Measured: Up to 40 months
Overall survival (OS)
OS was defined as the duration from the initiation of treatment to death of any cause
Measured: Up to 40 months
Eastern Cooperative Oncology Group (ECOG) score
0 - Fully active, able to carry on all pre-disease performance without restriction;
1. - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work;
2. - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours;
3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours;
4. - Completely disabled. Cannot carry out on any self-care; totally confined to bed or chair.
Measured: Up to 40 months

Timeline

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

Nov 2017Dec 2020

First posted29 Nov 2017
Study startNov 2017 (estimated)
Primary completionDec 2020 (estimated)
Study completionDec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by West China HospitalThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03356444
Sponsor's protocol ID: 2017-16
Status last verified: Nov 2017
First submitted: 9 Nov 2017
Last updated: 29 Nov 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Evaluation of First-line Treatment Efficacy of Docetaxel and Abiraterone in Metastatic Castration-resistant Prostate Cancer Patients With Intraductal Carcinoma of the Prostate and the Exploration of the Genes Related to Treatment Effect
ClinicalTrials.gov ID: NCT03356444
Acronym / sponsor ID: 2017-16
Conditions: Prostate Cancer, Castration-resistant Prostate Cancer, Drug
Keywords: abiraterone, docetaxel, Castration-resistant Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 140 participants (estimated)
Lead sponsor: West China HospitalUniversity, hospital or other
Study start: Nov 2017 (estimated)
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2020 (estimated)
First posted: 29 Nov 2017 (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
Abiraterone group	Experimental	Drug: Abiraterone AcetateAbiraterone acetate is administered in this arm.
Docetaxel group	Active comparator	Drug: DocetaxelDocetaxel is administered in this arm.

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Age: ≥40 years old
Positive IDC-P status confirmed by pathological examination.
Bone or visceral metastatic disease confirmed by image examination.
Castration resistant confirmed according to the criteria of 2014 EAU guidelines.
The ECOG score of the patient is ≤1

Key exclusion criteria (9 listed)

Patients who had other types of cancer besides prostate cancer were excluded.
Patients With non-acinar adenocarcinoma except intraductal carcinoma of the prostate, including ductal adenocarcinoma, neuroendocrine carcinoma or small cell carcinoma of the prostate.
Prior chemotherapy or abiraterone for the treatment of mCRPC.
Patients with renal decompensation requiring hemodialysis or peritoneal dialysis.
Patients with severe active clinical infection

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
Abiraterone AcetateAbiraterone Acetate: orally, 1000mg, qd, plus with prednisone orally, 5mg, bid. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs.	Drug	Abiraterone group
DocetaxelDocetaxel: intravenously, 75 mg/m^2, over 1 h every 3 weeks, plus with prednisone, orally, 10 mg, qd. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs. If no progression, stop until 10 cycles of traetment	Drug	Docetaxel group

Primary outcome

PSA-Progression free survival (PSA-PFS)
Time frame: Up to 40 months
PSA progression was defined as an increase in the PSA level of 25% or more above the nadir (and by ≥ 2 ng/ml), with confirmation of 4 or more weeks later.
Radiographic progression free survival (rPFS)
Time frame: Up to 40 months
rPFS was defined 1) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria; or 2) as at least two new lesions on first post-treatment bone scan, with at least two additional lesions on the next bone scan.

3 secondary outcomes

PSA response rate
Time frame: Up to 40 months
Overall survival (OS)
Time frame: Up to 40 months
Eastern Cooperative Oncology Group (ECOG) score
Time frame: Up to 40 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
Individual participant dataSharing planned: No

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate and Docetaxel in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by West China Hospital.

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 11 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

PSA-Progression free survival (PSA-PFS) (time frame: Up to 40 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 NCT03356444.

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 Nov 2017.