Metastatic Castration-resistent Prostate CancerPhase 3NCT04139772

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.

A Phase 3 study testing Docetaxel and Abiraterone Acetate or Enzalutamide in people with Metastatic Castration-resistent Prostate Cancer, run by National Cancer Institute, Naples at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Metastatic Castration-resistent Prostate Cancer
What is being tested?: Docetaxel and Abiraterone Acetate or Enzalutamide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteItaly
Study dates: 1 Sep 2019to 1 Jul 2024
Phase: Phase 3
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 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Naples, 80131

Other trials in Italy

About this study

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.

Read the 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.

Conditions: Metastatic Castration-resistent Prostate Cancer
Being tested: Docetaxel, Abiraterone Acetate or Enzalutamide
Keywords: metastatic castration-resistent prostate cancer, asymptomatic or oligosymptomatic, hormone therapy, docetaxel

What participants receive

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

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

Study groups in NCT04139772
Study group	Role	What they receive
Docetaxel	Active comparator	Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles. Receives: Drug: Docetaxel
Abiraterone or Enzalutamide	Experimental	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. Receives: Drug: Abiraterone Acetate or Enzalutamide

What is being measured

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

Overall survival (OS)
OS is defined as the time from randomization until death
Measured: up to 5 years

Secondary outcomes (9)

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.
Measured: up to 5 years
Time to Prostate-Specific Antigen (PSA) Progression
as determined by investigator
Measured: up to 5 years
Incidence of symptomatic skeletal events (SSE)
reporting the incidence and types of skeletal related events
Measured: up to 5 years
Time to symptomatic skeletal event (SSE)
Time from the date of randomization to the date of documented symptomatic skeletal event
Measured: up to 5 years
Time to Pain Progression
Time from the date of randomization to the date of pain progression
Measured: up to 5 years
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
Measured: baseline, during treatment (every 4 weeks) up to 5 years
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
Measured: baseline, during treatment up to 5 years
Radiographic response (bone lesions)
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: up to 5 years
Radiographic response (soft tissue lesions)
Prostate Cancer Working Group 3 (PCWG3) criteria
Measured: up to 5 years

Timeline

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

1 Sep 20191 Jul 2024

First posted25 Oct 2019
Study start1 Sep 2019
Primary completion1 Dec 2023 (estimated)
Study completion1 Jul 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Castration-resistent Prostate CancerStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment Comparative Randomized Phase 3 Design
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04139772
Sponsor's protocol ID: Meet-Uro4
Status last verified: Mar 2023
First submitted: 30 Sep 2019
Last updated: 24 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04139772
Acronym / sponsor ID: Meet-Uro4
Conditions: Metastatic Castration-resistent Prostate Cancer
Keywords: metastatic castration-resistent prostate cancer, asymptomatic or oligosymptomatic, hormone therapy, docetaxel
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 18 participants (actual)
Lead sponsor: National Cancer Institute, NaplesUniversity, hospital or other
Study start: 1 Sep 2019 (actual)
Primary completion: 1 Dec 2023 (estimated)
Study completion: 1 Jul 2024 (estimated)
First posted: 25 Oct 2019 (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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel Assignment Comparative Randomized Phase 3 Design

Arm	Type	Receives
Docetaxel	Active comparator	Drug: DocetaxelDocetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.
Abiraterone or Enzalutamide	Experimental	Drug: Abiraterone Acetate or EnzalutamidePatient 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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)

Key exclusion criteria (22 listed)

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

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
DocetaxelDocetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.	Drug	Docetaxel
Abiraterone Acetate or EnzalutamidePatient 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.	Drug	Abiraterone or Enzalutamide

Primary outcome

Overall survival (OS)
Time frame: up to 5 years
OS is defined as the time from randomization until death

9 secondary outcomes

Progression free survival (PFS)
Time frame: up to 5 years
Time to Prostate-Specific Antigen (PSA) Progression
Time frame: up to 5 years
Incidence of symptomatic skeletal events (SSE)
Time frame: up to 5 years
Time to symptomatic skeletal event (SSE)
Time frame: up to 5 years
Time to Pain Progression
Time frame: up to 5 years
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0
Time frame: baseline, during treatment (every 4 weeks) up to 5 years
Determination of changes in quality of life
Time frame: baseline, during treatment up to 5 years
Radiographic response (bone lesions)
Time frame: up to 5 years
Radiographic response (soft tissue lesions)
Time frame: up to 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
Individual participant dataSharing planned: No

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.

Sandro Pignata, MD, PhD principal investigator

National Cancer Institute, Naples

Gaetano Facchini, MD principal investigator

National Cancer Institute, Naples

Francesco Perrone, MD, PhD principal investigator

National Cancer Institute, Naples

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel and Abiraterone Acetate or Enzalutamide in people with Metastatic Castration-resistent Prostate Cancer, run by National Cancer Institute, Naples at 1 site in Italy.

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 10 inclusion and 22 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 24 Mar 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 Italy. 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival (OS) (time frame: up to 5 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 NCT04139772.

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 24 Mar 2023.