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Prostatic NeoplasmsPhase 2CHEIRONNCT02453009

Addition of Enzalutamide to First Line Docetaxel for Castration Resistant Prostate Cancer

A Phase 2 study testing Docetaxel, Prednisone and Enzalutamide in people with Prostatic Neoplasms, run by Santa Chiara Hospital at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to improve the disease control in first line CRPC patients. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Docetaxel, Prednisone and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteItaly
Study dates
Oct 2014to Apr 2019
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

  • Histologically- or cytologically-confirmed prostate adenocarcinoma.
  • Metastatic disease.
  • Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following:
  • Increase in measurable disease (RECIST 1.1) [15], and/or
  • Appearance of new lesions, including those on bone scan consistent with progressive prostate cancer, and/or
  • Rising PSA defined as 2 sequential increases above a previous lowest reference value. Each value must be obtained at least 1 week apart. A PSA value of at least 2 ng/ml is required at study entry.
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  • Effective castration (serum testosterone levels ≤0.50 ng/dL) by orchiectomy and/or LHRH agonists or antagonist with or without anti-androgens.
  • If the patient has been treated with LHRH agonists or antagonist (i.e., without orchiectomy), then this therapy should be continued.
  • If patients were either started on complete androgen blockade, or had a PSA response (defined by any reduction in PSA sustained for at least 3 months) after adding an antiandrogen, prior anti-androgen therapy should be stopped before randomization: at least 6 weeks for bicalutamide and nilutamide, and at least 4 weeks for flutamide, megestrol acetate and any other hormonal therapy.
  • More than 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix 2).
  • Ability to fill the quality of life questionnaire
  • Patient compliance and geographic proximity that allow adequate follow-up.
  • Presence of signed and dated IRB-approved patient informed consent form prior to enrollment into the study.

Who cannot join

  • Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago.
  • Prior treatment with abiraterone acetate and/or enzalutamide
  • Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Patients may be on biphosphonates prior to study entry.
  • Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
  • History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
  • History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months of randomization;
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  • Inadequate organ and bone marrow function
  • Contraindications to the use of corticosteroid treatment.
  • Clinically significant cardiovascular disease
  • Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
  • Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed >5 years ago and from which the patient has been disease-free for >5 years.
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
  • Any other condition which in the judgment of the investigator would place the subject at undue risk or interfere with the study.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Santa Chiara Hospital

    Trento, 38122

Other trials in Italy

About this study

Official title: CHemotherapy Plus Enzalutamide In First Line Therapy for Castration Resistant prOstate caNcer

The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to improve the disease control in first line CRPC patients.

Read the detailed description

CHEIRON trial is a phase II randomized study comparing docetaxel plus enzalutamide to docetaxel alone as first line for castration resistant prostate cancer.

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

    Pharmaceutical form:solution Route of administration: intravenous

  • PrednisoneDrug

    Pharmaceutical form:tablet Route of administration: oral

  • EnzalutamideDrug

    Also called Xtandi

    Pharmaceutical form : soft gelatin capsules Route of administration: oral

Study groups in NCT02453009
Study groupRoleWhat they receive
Arm AExperimentalDocetaxel 75 mg/m² intravenously on day 1 every 3 weeks for 8 cycles, plus oral prednisone 10 mg daily for 24 weeks plus oral enzalutamide 160 mg daily for 24 weeks
Receives: Drug: Docetaxel; Drug: Prednisone; Drug: Enzalutamide
Arm BActive comparatorDocetaxel 75 mg/m² intravenously on day 1 every 3 weeks for 8 cycles, plus oral prednisone 10 mg daily for 24 weeks
Receives: Drug: Docetaxel; Drug: Prednisone

What is being measured

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

  1. Rate of patients without progression (according to guideline of Prostate Cancer Clinical Trials Working Group 2 - PCWG2)

    Rate of patients without progression (according to guideline of Prostate Cancer

    Measured: 6 months after docetaxel first administration

Secondary outcomes (11)

  1. Rate of objective response according to RECIST criteria

    Rate of objective response according to RECIST criteria

    Measured: 6 months after docetaxel first administration

  2. Rate of biochemical response according to PCWG2

    Rate of biochemical response according to PCWG2

    Measured: 6 months after docetaxel first administration

  3. Kaplan-Meier estimates of progression-free survival

    Kaplan-Meier estimates of progression-free survival

    Measured: 6 months after docetaxel first administration

  4. Kaplan-Meier estimates of overall survival

    Kaplan-Meier estimates of overall survival

    Measured: 6 months after docetaxel first administration

  5. Kaplan-Meier estimates of biochemical progression-free survival

    Kaplan-Meier estimates of biochemical progression-free survival

    Measured: 6 months after docetaxel first administration

  6. Rate of treatment-related mortality

    Rate of treatment-related mortality

    Measured: 6 months after docetaxel first administration

  7. Rate of toxicity-related protocol withdrawal

    Rate of toxicity-related protocol withdrawal

    Measured: 6 months after docetaxel first administration

  8. Scales of brief pain inventory (BPI)

    Scales of brief pain inventory (BPI

    Measured: 6 months after docetaxel first administration

  9. Analgesic score

    Analgesic score

    Measured: 6 months after docetaxel first administration

  10. Functional scales and items of FACT - P questionnaire

    Functional scales and items of FACT - P questionnaire

    Measured: 6 months after docetaxel first administration

  11. Type and grade of any adverse reaction to treatment, according to CTC-AE v. 4.03

    Type and grade of any adverse reaction to treatment, according to CTC-AE v. 4.03

    Measured: 6 months after docetaxel first administration

Timeline

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

  1. First posted25 May 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionApr 2018
  4. Study completionApr 2019

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02453009
Sponsor's protocol ID
TN-CHEIRON
Acronym
CHEIRON
Status last verified
May 2024
First submitted
19 May 2015
Last updated
30 May 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Caffo O, Ortega C, Nole F, Gasparro D, Mucciarini C, Aieta M, Zagonel V, Iacovelli R, De Giorgi U, Facchini G, Veccia A, Palesandro E, Verri E, Buti S, Razzini G, Bozza G, Maruzzo M, Ciccarese C, Schepisi G, Rossetti S, Maines F, Kinspergher S, Fratino L, Ermacora P, Nicodemo M, Giordano M, Sartori D, Scapoli D, Sabbatini R, Lo Re G, Morelli F, D'Angelo A, Vittimberga I, Lippe P, Carrozza F, Messina C, Galli L, Valcamonico F, Porta C, Pappagallo G, Aglietta M. Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial. Eur J Cancer. 2021 Sep;155:56-63. doi: 10.1016/j.ejca.2021.06.016. Epub 2021 Aug 3.

    PubMed 34358777

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Prednisone and Enzalutamide in people with Prostatic Neoplasms, run by Santa Chiara Hospital 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 14 inclusion and 14 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: finished, as of the sponsor's last update on 30 May 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 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of patients without progression (according to guideline of Prostate Cancer Clinical Trials Working Group 2 - PCWG2) (time frame: 6 months after docetaxel first administration). 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 NCT02453009, which also lists 1 linked publication.

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 30 May 2024.

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