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

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ClinicalTrials.gov Identifier: NCT03314324
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE October 13, 2017
First Posted Date  ICMJE October 19, 2017
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE November 29, 2017
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2017)
Patient preference [ Time Frame: up to 24 months ]
Patient preference (assessed by a single question) between ODM-201 and enzalutamide after completion of the second period of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03314324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer
Official Title  ICMJE A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer
Brief Summary To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Prospective, randomized, open-label, multicenter, cross-over phase II trial
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Castrate-resistant Prostate (CRPC) Cancer
Intervention  ICMJE
  • Drug: ODM-201
    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.
  • Drug: Enzalutamide
    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 Arms  ICMJE
  • Experimental: ODM-201
    Intervention: Drug: ODM-201
  • Active Comparator: Enzalutamide
    Intervention: Drug: Enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2017)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • ECOG 0-1 (2 is accepted if the impairement is not due to prostate cancer)
  • Asymptomatic or mildly symptomatic (Brief Pain Inventory<4) prostate cancer
  • 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.

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karim FIZAZI, MD, PhD 0142114317 ext +33 karim.fizazi@gustaveroussy.fr
Contact: Geraldine MARTINEAU, MD 0142115607 ext +33 geraldine.martineau@gustaveroussy.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03314324
Other Study ID Numbers  ICMJE 2017-001606-14
2017/2555 ( Other Identifier: CSET number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Karim FIZAZI, MD Gustave ROUSSY
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP