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Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.

Primary Purpose

Metastatic Castration-resistent Prostate Cancer

Status

Active

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Docetaxel

Abiraterone Acetate or Enzalutamide

About this trial

This is an interventional treatment trial for Metastatic Castration-resistent Prostate Cancer focused on measuring metastatic castration-resistent prostate cancer, asymptomatic or oligosymptomatic, hormone therapy, docetaxel

Eligibility Criteria

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

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate
Distant metastatic disease
Previous first line treatment with abiraterone or enzalutamide for 6 cycles interrupted at least 2 weeks before randomization
Patients must be ≥ 18 years of age
Patients must have castrate serum level of testosterone of < 0.5 ng/mL ( 1.7 nmol/L)
Asymptomatic or Oligosymptomatic disease
Progressive disease according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
ECOG performance status (PS) of 0-2
Sexually active males must use an accepted and effective method birth control measure
Written informed consent

Exclusion Criteria:

Prior exposure to docetaxel or abiraterone for treatment of hormone-sensitive metastatic prostate cancer (mHSPC)
History of adrenal insufficiency or hypoaldosteronism
Any medical condition that would make prednisone use contraindicated
Any medical condition that would make docetaxel use contraindicated
Patients unable to swallow orally administered medication
Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) requiring antiretroviral therapy
Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, bladder cancer (pTis, pTa, pT1) or other solid tumours curatively treated with no evidence of disease for > 5 years
Participation in another clinical study with an investigational product within 30 days prior to randomization
Persistent toxicities [>Common Terminology Criteria for Adverse Event (CTCAE) grade 1)] caused by previous cancer therapy prior to randomization
Uncontrolled medical conditions including diabetes mellitus. Clinically significant cardiovascular disease (e.g.: uncontrolled hypertension or arrhythmia, unstable angina pectoris, congestive heart failure (CHF), vascular disease (arterial thrombosis) and myocardial infarction within < 6 months
Left ventricular ejection fraction < 50%
Peripheral neuropathy [> CTCAE grade 2]
Inadequate bone marrow function defined as:
- haemoglobin < 9.0 g/dL
- absolute neutrophils count (ANC) <1.5 x 109/L (> 1500 per mm3)
- platelet count <100 x 109/L (>100,000 per mm3)
Inadequate renal and hepatic function, defined as:
- total serum bilirubin > 1,0 x ULN
- AST/SGOT o ALT/SGPT > 1,5 x ULN
- calculated creatinine clearance < 40 mL/min
- potassium level < 3,5 mmol/L
- Child-Pugh class C

Sites / Locations

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Docetaxel

Abiraterone or Enzalutamide

Arm Description

Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.

Patient will receive Abiraterone or Enzalutamide based on previous treatment. Abiraterone given orally at the dose of 1000 mg daily plus oral prednisone 5 mg twice daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment. Enzalutamide given orally at the dose of 160 mg daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.

Outcomes

Primary Outcome Measures

Overall survival (OS)

OS is defined as the time from randomization until death

Secondary Outcome Measures

Progression free survival (PFS)

PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first.

Time to Prostate-Specific Antigen (PSA) Progression

as determined by investigator

Incidence of symptomatic skeletal events (SSE)

reporting the incidence and types of skeletal related events

Time to symptomatic skeletal event (SSE)

Time from the date of randomization to the date of documented symptomatic skeletal event

Time to Pain Progression

Time from the date of randomization to the date of pain progression

Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

Determination of changes in quality of life

EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis

Radiographic response (bone lesions)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Radiographic response (soft tissue lesions)

Prostate Cancer Working Group 3 (PCWG3) criteria

Full Information

NCT ID

NCT04139772

First Posted

September 30, 2019

Last Updated

March 23, 2023

Sponsor

National Cancer Institute, Naples

1. Study Identification

Unique Protocol Identification Number

NCT04139772

Brief Title

Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.

Official Title

A Randomized Multicenter Phase III Trial Comparing Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized phase 3 trial aiming to compare the efficacy of docetaxel and hormone therapy as second line treatment in patients with mCRPC progressing after therapy with abiraterone or enzalutamide.

Detailed Description

Patients will be randomized 1:1 to receive docetaxel or hormone therapy (abiraterone or enzalutamide based on previous treatment). Docetaxel (standard) will be administered for 10 cycles (maximum). Hormone therapy (experimental) will be administered until progression or unacceptable toxicity.

6. Conditions and Keywords

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

Metastatic Castration-resistent Prostate Cancer

Keywords

metastatic castration-resistent prostate cancer, asymptomatic or oligosymptomatic, hormone therapy, docetaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment Comparative Randomized Phase 3 Design

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel

Arm Type

Active Comparator

Arm Description

Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.

Arm Title

Abiraterone or Enzalutamide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.

Intervention Type

Drug

Intervention Name(s)

Abiraterone Acetate or Enzalutamide

Intervention Description

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

OS is defined as the time from randomization until death

Time Frame

up to 5 years

Secondary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first.

Time Frame

up to 5 years

Title

Time to Prostate-Specific Antigen (PSA) Progression

Description

as determined by investigator

Time Frame

up to 5 years

Title

Incidence of symptomatic skeletal events (SSE)

Description

reporting the incidence and types of skeletal related events

Time Frame

up to 5 years

Title

Time to symptomatic skeletal event (SSE)

Description

Time from the date of randomization to the date of documented symptomatic skeletal event

Time Frame

up to 5 years

Title

Time to Pain Progression

Description

Time from the date of randomization to the date of pain progression

Time Frame

up to 5 years

Title

Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

Description

graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

Time Frame

baseline, during treatment (every 4 weeks) up to 5 years

Title

Determination of changes in quality of life

Description

EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis

Time Frame

baseline, during treatment up to 5 years

Title

Radiographic response (bone lesions)

Description

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time Frame

up to 5 years

Title

Radiographic response (soft tissue lesions)

Description

Prostate Cancer Working Group 3 (PCWG3) criteria

Time Frame

up to 5 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male patients with metastatic castration resistent prostate cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate Distant metastatic disease Previous first line treatment with abiraterone or enzalutamide for 6 cycles interrupted at least 2 weeks before randomization Patients must be ≥ 18 years of age Patients must have castrate serum level of testosterone of < 0.5 ng/mL ( 1.7 nmol/L) Asymptomatic or Oligosymptomatic disease Progressive disease according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria ECOG performance status (PS) of 0-2 Sexually active males must use an accepted and effective method birth control measure Written informed consent Exclusion Criteria: Prior exposure to docetaxel or abiraterone for treatment of hormone-sensitive metastatic prostate cancer (mHSPC) History of adrenal insufficiency or hypoaldosteronism Any medical condition that would make prednisone use contraindicated Any medical condition that would make docetaxel use contraindicated Patients unable to swallow orally administered medication Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) requiring antiretroviral therapy Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, bladder cancer (pTis, pTa, pT1) or other solid tumours curatively treated with no evidence of disease for > 5 years Participation in another clinical study with an investigational product within 30 days prior to randomization Persistent toxicities [>Common Terminology Criteria for Adverse Event (CTCAE) grade 1)] caused by previous cancer therapy prior to randomization Uncontrolled medical conditions including diabetes mellitus. Clinically significant cardiovascular disease (e.g.: uncontrolled hypertension or arrhythmia, unstable angina pectoris, congestive heart failure (CHF), vascular disease (arterial thrombosis) and myocardial infarction within < 6 months Left ventricular ejection fraction < 50% Peripheral neuropathy [> CTCAE grade 2] Inadequate bone marrow function defined as: haemoglobin < 9.0 g/dL absolute neutrophils count (ANC) <1.5 x 109/L (> 1500 per mm3) platelet count <100 x 109/L (>100,000 per mm3) Inadequate renal and hepatic function, defined as: total serum bilirubin > 1,0 x ULN AST/SGOT o ALT/SGPT > 1,5 x ULN calculated creatinine clearance < 40 mL/min potassium level < 3,5 mmol/L Child-Pugh class C

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandro Pignata, MD, PhD

Organizational Affiliation

National Cancer Institute, Naples

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gaetano Facchini, MD

Organizational Affiliation

National Cancer Institute, Naples

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francesco Perrone, MD, PhD

Organizational Affiliation

National Cancer Institute, Naples

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Orazio Caffo, MD

Organizational Affiliation

Oncology Department, Ospedale Santa Chiara, Trento

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Clorinda Schettino, MD

Organizational Affiliation

National Cancer Institute, Naples

Official's Role

Study Chair

Facility Information:

Facility Name

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

City

Napoli

ZIP/Postal Code

80131

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

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