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Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer (PC-ARN)

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ClinicalTrials.gov Identifier: NCT03088124
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Tracking Information
First Submitted Date  ICMJE March 13, 2017
First Posted Date  ICMJE March 23, 2017
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE April 28, 2017
Estimated Primary Completion Date April 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
Time to initiate a local treatment. [ Time Frame: from randomization to local treatment initiation (up to 3 years) ]
Date of randomization and date at which local treatment is initiated
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
  • Time to another prostate treatment initiation (excluding local treatment) [ Time Frame: from randomization to prostate treatment initiation up to 3 years ]
    Date of randomization, date of treatment initiation (other than local)
  • Prostate Specific Antigen (PSA) and Testosterone dosages [ Time Frame: PSA: at screening and at 3, 6, 9,12,18, 24, 30, 36 months visits. Testosterone: at screening, 12, 24 and 36 months visits ]
    Biological assessment
  • Prostate biopsy and Gleason score [ Time Frame: At screening and at 12, 24 and 36 months visits ]
    histological assessment
  • Tumor radiological progression [ Time Frame: At screening and at 24 months-visit ]
    Radiological assessment by multi-parametric MRI: normal versus anormal
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer
Official Title  ICMJE Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial
Brief Summary

Many prostate cancer are slow or non progressive forms that would never impair quality or quantity of like of life if undetected. For this localized prostate cancer, the recommendation is an active surveillance, however often experienced by the patient as a lack of care. Thus the introduction of new potent androgen receptor inhibitor raise the question of the benefit of early hormonal therapy in localized prostate cancers.

The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.

Detailed Description

Several cohort studies have demonstrated that survival time in patients with untreated early stage prostate cancer is greater than 10 years in more than 70% of cases, suggesting the existence of slowly progressive or non-progressive forms of prostate cancer that would never cause any impairment to quality or quantity of life if undetected. These forms represent currently 23% to 67% of all prostate cancers. Therefore, while men's lifetime risk of prostate cancer is high (16-18%), the corresponding risk of death is only about 3%. These observations gave the opportunity to consider, near the current standard and curative treatment, an active surveillance. This therapeutically choice offers the ability to delay or avoid definitive treatment, thereby minimizing patient morbidity. Studies to date have shown that this seems to be achieved without compromising long term outcomes (progression-free survival) in appropriately selected patients. Up to one third of them receive further treatment after a median of about 2,5 years of surveillance. However, even if active surveillance is associated with the highest quality-adjusted life expectancy when compared with local treatment, active surveillance is often experienced as a lack of care, some patients undergoing surveillance experience disutility related to anxiety which can significantly affect their quality of life.

The introduction of new potent androgen receptor inhibitors able to block several steps in the androgen receptors signaling pathway, raise the question again of the benefit of early hormonal therapy in localized prostate cancers. The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Risk Prostate Cancer
Intervention  ICMJE Drug: Apalutamide
Patients will take orally everyday 240 mg of Apalutamide.
Other Name: ARN-509
Study Arms  ICMJE
  • No Intervention: active surveillance
    Active surveillance without androgen deprivation
  • Experimental: active surveillance with Apalutamide
    Active surveillance during and after 6 months treatment with Apalutamide
    Intervention: Drug: Apalutamide
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: March 17, 2017)
206
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2022
Estimated Primary Completion Date April 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Out-patient aged ≥ 18 years old
  2. With life expectancy of more than 5 years
  3. With ECOG performance status = 0 or 1
  4. Having read, understood, signed and dated the informed consent,
  5. With a Localized prostate cancer diagnozes within less than 7 months and defined by:

    • Clinical Stage: T1c or T2a
    • Sampled biopsy with less of 3 positive cores and tumor length < 3 mm per core (<7 mm for targeted cores)
    • Gleason score < 7 (3+4 for patients >70years if small volume tumor)
    • PSA levels ≤ 10 ng/ml or PSA density <0.2ng/ml/ml
  6. Clinical laboratory values at screening:

    1. Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
    2. Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
    3. Serum albumin ≥3.0 g/dL
    4. Serum creatinine <2.0 × upper limit of normal (ULN)
    5. Serum potassium ≥3.5 mmol/L
    6. Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
    7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
  7. Medications known to lower the seizure threshold (see list in appendix 2) must be discontinued or substituted at least 4 weeks prior to study entry.
  8. Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
  9. Having accepted the principle of active surveillance
  10. Who is willing to participate to the study for a minimum period of 36 months
  11. Able to swallow the study drug and comply with study requirements
  12. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.

Exclusion Criteria:

  1. Prior treatment for prostate cancer with surgery or radiotherapy or including 5-alpha reductase inhibitor (finasteride or dutasteride) and antiandrogen
  2. Absolute neutrophil count < 1,500/μL,
  3. Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  4. Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
  5. Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  6. Uncontrolled hypertension (SBP≥160 mmHg or DBP≥90 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  7. Gastrointestinal disorder affecting absorption
  8. Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  9. Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
  10. Mental deficiency or any other reason that may hinder the understanding or the strict application of the Protocol
  11. Patient placed under judicial protection, tutorship, or curatorship
  12. Patient unlikely to attend control visits
  13. Patient currently enrolled in an investigational study or having participated to another investigational study within the past 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominique GENRE, MD 33 4 91 22 37 78 drci.up@ipc.unicancer.fr
Contact: Margot BERLINE, MSc, MBA 33 4 91 22 33 14 drci.up@ipc.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03088124
Other Study ID Numbers  ICMJE PC-ARN IPC-2015-025
Has Data Monitoring Committee No
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 Not Provided
Responsible Party Institut Paoli-Calmettes
Study Sponsor  ICMJE Institut Paoli-Calmettes
Collaborators  ICMJE Janssen-Cilag Ltd.
Investigators  ICMJE
Principal Investigator: Gwenaelle GRAVIS, MD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date September 2019

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