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Prostate CancerPhase 2NCT03700099

Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Treatment With Docetaxel Followed by Enzalutamide

A Phase 2 study testing Docetaxel and Enzalutamide in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 prospective biomarker study of patients with metastatic castration-resistant prostate cancer (mCRPC) undergoing sequential treatment with docetaxel and enzalutamide. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Docetaxel and Enzalutamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
3 Sep 2019to 1 Apr 2025
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Men diagnosed with metastatic prostate cancer, with at least one metastatic lesion on CT or bone scan.
  • Documentation of castrate levels of testosterone (< 50 ng per deciliter), and continued androgen deprivation therapy or surgical castration.
  • Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy:
  • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥
  • 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥ 4 weeks since last flutamide, bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL);
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  • Soft tissue disease progression defined by RECIST 1.1;
  • Bone disease progression defined by PCWG2 with two or more new lesions on bone scan.
  • No prior chemotherapy for mCRPC.
  • Patients previously treated with bicalutamide, ketoconazole, or estrogens will be eligible. These patients must have discontinued therapy ≥ 4 weeks prior to enrollment.
  • Patients previously treated with steroids or receiving prednisone or dexamethasone will be eligible. In this case, continuing therapy will be at the discretion of the attending physician.
  • Patients who are candidates for therapy with docetaxel and enzalutamide.
  • Patients must agree to undergo pre- and post-therapy blood collection.
  • Patients must understand and be willing to sign the written informed consent form of this study.

Who cannot join

  • Patients with CRPC previously treated with chemotherapy.
  • Non-castrate levels of testosterone (> 50 ng per deciliter) or inability to continue androgen deprivation therapy during the study period.
  • Absence of detectable metastasis on imaging studies.
  • Prior therapy with abiraterone, enzalutamide or any investigational AR-directed agent.
  • Contra-indication for therapy with docetaxel or enzalutamide.
  • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months of enrollment.
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  • Known or suspected brain metastasis or active leptomeningeal disease.
  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
  • History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer;
  • Absolute neutrophil count < 1,500/μL, or platelet count < 100,000/μL, or hemoglobin < 9 g/dL at the Screening visit;
  • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at the screening visit (for Docetaxel phase only);
  • Creatinine > 2 mg/dL at the Screening visit (for Docetaxel phase only);
  • Albumin < 3.0 g/dL at the Screening visit (for Docetaxel phase only);
  • Clinically significant cardiovascular disease including:
  • Myocardial infarction within 6 months;
  • Uncontrolled angina within 3 months;
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
  • Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the screening visit;
  • Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG;
  • Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit;
  • Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
  • Major surgery within 4 weeks of enrollment (Day 1 Visit);
  • Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment (Day 1 visit);
  • Treatment with flutamide, bicalutamide or nilutamide within 4 weeks of enrollment (Day 1 visit);
  • Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens, cytproterone within 4 weeks of enrollment (Day 1 visit)
  • Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH analogue therapy) or other agents with anti-tumor activity within 4 weeks of enrollment (Day 1 visit);
  • Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700) or targets the androgen receptor, including enzalutamide.
  • Use of an investigational agent within 4 weeks of enrollment (Day 1 visit);
  • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit);
  • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data;
  • Participation in a previous clinical trial of enzalutamide or an investigational agent that inhibits the androgen receptor or androgen synthesis.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Câncer do Estado de São Paulo

    São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: Prospective Biomarker Analysis of Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Undergoing Sequential Treatment With Docetaxel and Enzalutamide

This is a prospective biomarker study of patients with metastatic castration-resistant prostate cancer (mCRPC) undergoing sequential treatment with docetaxel and enzalutamide. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study. The primary goal of this study is to evaluate the association of the AR-V7 status and androgen receptor (AR) gene alterations with PSA response to docetaxel and enzalutamide.

Read the detailed description

This study is a prospective biomarker study of patients with metastatic castration-resistant prostate cancer (mCRPC) undergoing sequential treatment with docetaxel followed by enzalutamide. In this study, all participants will receive standard of care treatment with docetaxel 75 mg/m2 every 3 weeks up to 10 cycles and after progression, patients will receive enzalutamide 160 mg daily until limiting toxicity or disease progression. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Being tested
Docetaxel, Enzalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • DocetaxelDrug

    Also called Chemotherapy

    Docetaxel 75 mg/m2 IV every 3 weeks, for 6-10 cycles.

  • EnzalutamideDrug

    Also called Xtandi

    Upon disease progression after treatment with docetaxel, patients will receive Enzalutamide 160 mg P.O. daily until disease progression or limiting toxicity.

Study groups in NCT03700099
Study groupRoleWhat they receive
Study cohortOtherDocetaxel 75 mg/m2 i.v. every 3 weeks for 6-10 cycles. Upon disease progression after docetaxel, participants will receive enzalutamide 160 mg p.o. daily until limiting toxicity or disease progression.
Receives: Drug: Docetaxel; Drug: Enzalutamide

What is being measured

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

  1. Correlate AR-V7 status in circulating tumor cells (positive versus negative) and PSA response decline > 50% after therapy with docetaxel

    Measured: 6 months

  2. Correlate AR-V7 status in circulating tumor cells (positive versus negative) and PSA decline > 50% after therapy with enzalutamide

    Measured: 12 months

  3. Correlate AR mutations (present versus absent) and PSA response decline > 50% after therapy with docetaxel.

    Measured: 6 months

  4. Correlate AR mutations (present versus absent) and PSA response decline > 50% after therapy with enzalutamide.

    Measured: 12 months

Secondary outcomes (6)

  1. Correlate AR-V7 status in circulating tumor cells (positive versus negative) and time to PSA progression after docetaxel.

    Measured: 12 months

  2. Correlate AR-V7 status in circulating tumor cells (positive versus negative) and time to PSA progression after enzalutamide.

    Measured: 12 months

  3. Correlate AR mutations (present versus absent) and time to PSA progression after docetaxel.

    Measured: 12 months

  4. Correlate AR mutations (present versus absent) and time to PSA progression after enzalutamide.

    Measured: 12 months

  5. Correlate AR-V7 status in circulating tumor cells (positive versus negative) and overall survival.

    Measured: 24 months

  6. Correlate AR mutations (present versus absent) and median overall survival.

    Measured: 24 months

Timeline

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

  1. First posted9 Oct 2018
  2. Study start3 Sep 2019
  3. Primary completion1 Mar 2024
  4. Study completion1 Apr 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03700099
Sponsor's protocol ID
NP 1082/17
Status last verified
Apr 2024
First submitted
14 Sep 2018
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Enzalutamide in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

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 14 inclusion and 33 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 15 Apr 2024. 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 Brazil. 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 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?

Correlate AR-V7 status in circulating tumor cells (positive versus negative) and PSA response decline > 50% after therapy with docetaxel (time frame: 6 months). The study lists 4 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 NCT03700099.

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 15 Apr 2024.

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