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

NCT03356444 | Unknown Phase 2 FDA Drug

• 1 other identifier: 2017-16
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer; Castration-resistant Prostate Cancer; Drug

Keywords

abiraterone; docetaxel; Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 40 months

Secondary Outcomes (3)

• PSA response rate

  Up to 40 months

• Overall survival (OS)

  Up to 40 months

• Eastern Cooperative Oncology Group (ECOG) score

  Up to 40 months

Study Arms (2)

Abiraterone group

EXPERIMENTAL

Abiraterone acetate is administered in this arm.

Drug: Abiraterone Acetate

Docetaxel group

ACTIVE COMPARATOR

Docetaxel is administered in this arm.

Drug: Docetaxel

Interventions

Abiraterone Acetate DRUG

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

Abiraterone group

Docetaxel DRUG

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

Docetaxel group

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Only male patient can enter this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The administration methods of the two groups are different, therefore, the investigators decide not to use masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 29, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 29, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share