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Metastatic Castrate-resistant Prostate (CRPC) CancerPhase 2ODENZANCT03314324

A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer

A Phase 2 study testing ODM-201 and Enzalutamide in people with Metastatic Castrate-resistant Prostate (CRPC) Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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

To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
ODM-201 and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteFrance
Study dates
29 Nov 2017to 25 Sep 2024
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

  • Male patients older than 18 years
  • Histologically confirmed adenocarcinoma of the prostate
  • Evidence of metastatic disease (imaging can include bon scan, CT scan, PET choline, PET PSMA and MRI)
  • Continued androgen deprivation therapy (ADT) either with LHRH agonists/antagonists or bilateral orchiectomy
  • Serum testosterone <0.50 ng/ml (1.7 nmol/L)
  • Progressive disease (PSA progression or radiological progression or clinical progression) as per PCWG3 criteria
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  • ECOG 0-1 (2 is accepted if the impairment is not due to prostate cancer)
  • Asymptomatic or mildly symptomatic prostate cancer as measured on the Brief Pain Inventory Short Form question 3 (i.e. worst pain in the last 24 hours <4 on a Visual Analog Scale)
  • Information imparted to the patient and the informed consent form signed by the patient or his legal representative
  • Ability to comply with the protocol procedures
  • Patient affiliated to a social security system or beneficiary of the same
  • Sexually active male subjects unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the study treatment and for 3 months after the end of the treatment
  • adequate organ or bone marrow function as evidenced by:
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1.5 x 109/L,
  • Platelet count ≥ 100 x 109/L, (subject must not have received any growth factor within 4 weeks or blood transfusion within 7 days of the hematology laboratory sample obtained at screening)
  • AST/SGOT and/or ALT/SGPT ≤1.5 x ULN;
  • Total bilirubin ≤ 1.5 x ULN, (except subjects with a diagnosis of Gilbert's disease),
  • Serum creatinine ≤ 2 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to the CKDEPI formula and patients with creatinine clearance <60 mL/min should be excluded.

Who cannot join

  • Prior treatment with abiraterone, enzalutamide, ODM-201, ARN- 509 or any other next-generation AR axis-targeting drug
  • Prior treatment with a taxane for CRPC (prior treatment with a taxane for castration-sensitive or castration-naïve prostate cancer is allowed)
  • Prior treatment with radium-223
  • Patients receiving an investigational drug within 4 weeks prior to enrolment (approved drugs with a long history of use such as aspirin, statins, heparins, or metformin, even used in an experimental setting are accepted)
  • Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
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  • Acute toxicities of prior treatments and procedures not resolved to grade <=1 or baseline before randomisation.
  • Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association (NYHA) Class III or IV)
  • Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal medical management
  • Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free
  • A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment
  • An active viral hepatitis, active human immunodeficiency infection(HIV), or chronic liver disease with a need for treatment.
  • Any other serious or unstable illness or infection, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
  • Inability to swallow oral medications

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire

Being tested
ODM-201, Enzalutamide
Medical subject headings
Neoplasms

What participants receive

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

  • ODM-201Drug

    ODM-201: 600 mg (2 x 300 mg tablets) twice daily with food equivalent to a total daily dose of 1200 mg. ODM-201 should be taken at similar times day, approximately 12 hours between doses.

  • EnzalutamideDrug

    Enzalutamide: 160 mg/day (4 x 40 mg tablets) taken once a day preferably with food, preferably in the evening (Enzalutamide can generally be given with or without food, but in the present trial, it is preferable that it is given with food, to be consistent with ODM-201 intake).

Study groups in NCT03314324
Study groupRoleWhat they receive
ODM-201ExperimentalNot described
Receives: Drug: ODM-201
EnzalutamideActive comparatorNot described
Receives: Drug: Enzalutamide

What is being measured

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

  1. Patient preference

    Patient preference (assessed by a single question) between ODM-201 and enzalutamide after completion of the second period of treatment.

    Measured: up to 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 posted19 Oct 2017
  2. Study start29 Nov 2017
  3. Primary completion31 Jan 2022
  4. Study completion25 Sep 2024

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Prospective, randomized, open-label, multicenter, cross-over phase II trial
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314324
Sponsor's protocol ID
2017-001606-14
Other IDs
2017/2555, 2017
Acronym
ODENZA
Status last verified
Aug 2026
First submitted
13 Oct 2017
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Colomba E, Jonas SF, Eymard JC, Delva R, Brachet PE, Neuzillet Y, Penel N, Roubaud G, Bompas E, Mahammedi H, Longo R, Helissey C, Barthelemy P, Borchiellini D, Hasbini A, Priou F, Saldana C, Voog E, Narcisso B, Ladoire S, Berdah JF, Aisenfarb JB, Foulon S, Fizazi K. A Randomized, Open-label, Cross-over Phase 2 Trial of Darolutamide and Enzalutamide in Men with Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer: Patient Preference and Cognitive Function in ODENZA. Eur Urol. 2024 Mar;85(3):274-282. doi: 10.1016/j.eururo.2023.05.009. Epub 2023 Jun 2.

    PubMed 37271630

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ODM-201 and Enzalutamide in people with Metastatic Castrate-resistant Prostate (CRPC) Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 19 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 17 Aug 2026. 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 France. 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?

Patient preference (time frame: up to 24 months). 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 NCT03314324, 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 17 Aug 2026.

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