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

Primary Purpose

Prostate Cancer, Castration-resistant Prostate Cancer, Drug

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Abiraterone Acetate

Docetaxel

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring abiraterone, docetaxel, Castration-resistant Prostate Cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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
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.

Exclusion Criteria:

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
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abiraterone group

Docetaxel group

Arm Description

Abiraterone acetate is administered in this arm.

Docetaxel is administered in this arm.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

PSA response rate

PSA response is defined as ≥ 50% decline in PSA level from baseline, maintained for≥ 4 weeks

Overall survival (OS)

OS was defined as the duration from the initiation of treatment to death of any cause

Eastern Cooperative Oncology Group (ECOG) score

0 - Fully active, able to carry on all pre-disease performance without restriction; - 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; - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; - Completely disabled. Cannot carry out on any self-care; totally confined to bed or chair.

Full Information

NCT ID

NCT03356444

First Posted

November 9, 2017

Last Updated

November 22, 2017

Sponsor

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03356444

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2017 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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. Also, it's still not clear what's the best therapeutic choice for a certain group of patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Castration-resistant Prostate Cancer, Drug

Keywords

abiraterone, docetaxel, Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

The administration methods of the two groups are different, therefore, the investigators decide not to use masking.

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Abiraterone group

Arm Type

Experimental

Arm Description

Abiraterone acetate is administered in this arm.

Arm Title

Docetaxel group

Arm Type

Active Comparator

Arm Description

Docetaxel is administered in this arm.

Intervention Type

Drug

Intervention Name(s)

Abiraterone Acetate

Intervention Description

Abiraterone Acetate: orally, 1000mg, qd, plus with prednisone orally, 5mg, bid. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

PSA-Progression free survival (PSA-PFS)

Description

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.

Time Frame

Up to 40 months

Title

Radiographic progression free survival (rPFS)

Description

Time Frame

Up to 40 months

Secondary Outcome Measure Information:

Title

PSA response rate

Description

PSA response is defined as ≥ 50% decline in PSA level from baseline, maintained for≥ 4 weeks

Time Frame

Up to 40 months

Title

Overall survival (OS)

Description

OS was defined as the duration from the initiation of treatment to death of any cause

Time Frame

Up to 40 months

Title

Eastern Cooperative Oncology Group (ECOG) score

Description

Time Frame

Up to 40 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Only male patient can enter this study

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Exclusion Criteria: 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 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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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