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Trial record 1 of 1 for:    NCT01957436
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A Phase III of ADT +/- Docetaxel +/- Local RT +/- Abiraterone Acetate in Metastatic Hormone-naïve Prostate Cancer. (PEACE1)

This study is currently recruiting participants.
Verified October 2016 by UNICANCER
Sponsor:
ClinicalTrials.gov Identifier:
NCT01957436
First Posted: October 8, 2013
Last Update Posted: October 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Janssen-Cilag Ltd.
European Organisation for Research and Treatment of Cancer - EORTC
Ipsen
Information provided by (Responsible Party):
UNICANCER
  Purpose
This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy (+/- docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

Condition Intervention Phase
Prostate Cancer Adenocarcinoma Metastatic Drug: abiraterone acetate Radiation: radiotherapy Other: Androgen Deprivation Therapy Drug: Docetaxel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Phase III Study of Androgen Deprivation Therapy (+/- Docetaxel) With or Without Local Radiotherapy With or Without Abiraterone Acetate and Prednisone in Patient With Metastatic Hormone-naïve Prostate Cancer.

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Survival [ Time Frame: 5.5 years after the first inclusion ]
    Overall and progression-free survival


Secondary Outcome Measures:
  • PSA response rate [ Time Frame: 8 months ]
    The PSA response rate will be defined by an undetectable serum PSA level at 8 months

  • Prospective correlative study of PSA response/progression [ Time Frame: 8 months ]
  • Prostate cancer specific survival [ Time Frame: 5.5 years ]
  • Time to pain progression [ Time Frame: 5.5 years ]
    will be evaluated by questionnaires

  • Time to next skeletal-related event [ Time Frame: 5.5 years ]
  • Time to chemotherapy [ Time Frame: 5.5 years ]
  • Time to severe local symptoms [ Time Frame: 5.5 years ]
    The time to severe local symptoms (grade 3 and 4 events) related to tumor progression and/or radiotherapy long term side effects will be evaluated according to NCI-CTCAE v4.0

  • Toxicity [ Time Frame: 5.5 years ]
    Toxicity (with a specific focus on the use of long-term low-dose steroids) will be evaluated according to NCI-CTCAE v4.0

  • The radiological progression-free survival [ Time Frame: 5.5 years ]
  • Impact of radiotherapy protocol on outcome [ Time Frame: 5.5 years ]

Estimated Enrollment: 916
Study Start Date: October 2013
Estimated Study Completion Date: October 2023
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
androgen deprivation therapy (+/- docetaxel)
Other: Androgen Deprivation Therapy
The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy
Drug: Docetaxel
6 cycles at 75mg/m²/cycle, one cycle every 3 weeks
Experimental: Arm B
androgen deprivation therapy + abiraterone acetate + prednisone (+/- docetaxel)
Drug: abiraterone acetate
abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid
Other Name: Zytiga
Other: Androgen Deprivation Therapy
The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy
Drug: Docetaxel
6 cycles at 75mg/m²/cycle, one cycle every 3 weeks
Experimental: Arm C
Arm A + radiotherapy
Radiation: radiotherapy
74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)
Other: Androgen Deprivation Therapy
The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy
Drug: Docetaxel
6 cycles at 75mg/m²/cycle, one cycle every 3 weeks
Experimental: Arm D
Arm B + radiotherapy
Drug: abiraterone acetate
abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid
Other Name: Zytiga
Radiation: radiotherapy
74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)
Other: Androgen Deprivation Therapy
The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy
Drug: Docetaxel
6 cycles at 75mg/m²/cycle, one cycle every 3 weeks

Detailed Description:

Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.

The randomisation will result in the allocation of arm A (ADT), arm B (ADT + Abiraterone), arm C(ADT + radiotherapy) or arm D (ADT + Abiraterone + radiotherapy) in a 1:1:1:1 ratio.

The randomization will be stratified (by minimization) according to:

  • enrolment center,
  • performance status (0 vs. 1-2)
  • disease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.

CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).

When the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients. Patients from arm B and D will then stop abiraterone (in selected cases e.g. slow/asymptomatic progressions, the investigator may consider continuing ADT + abirateroneprednisone at CRPC, rather than switching directly to another therapy, for patients included in the abiraterone arms, the use of prednisone at this stage is left to the investigator decision).

Investigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines. Abiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate,
  2. Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes can be included if they have either:

    • At least one extra-pelvic lymph node ≥ 2 cm or
    • extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm
  3. Patients with ECOG ≤ 1 (PS 2 due to bone pain accepted),
  4. Life expectancy ≥ 6 months,
  5. Male aged ≥ 18 years old,
  6. Hemoglobin ≥ 10.0 g/dL,
  7. Platelet count ≥ 100,000/μL,
  8. Serum creatinine < 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min,
  9. Serum potassium ≥ 4.0 mmol/L,
  10. Serum bilirubin ≤ 1.5 x ULN (except documented Gilbert's disease); AST and ALT ≤ 2.5 x ULN (≤ 5 ULN in case of liver metastases),
  11. Patients might have received a maximum of 3 months of ADT before randomization,
  12. Patients might have received previous radiation therapy directed to bone lesions
  13. Patients able to take oral medication,
  14. Patients who have received the information sheet and signed the informed consent form,
  15. Male patients who are receiving the study treatment and have partners of childbearing potential are advised to use a method of birth control with adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of the study treatment.
  16. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
  17. Patients with a public or a private health insurance coverage,

    Additional criteria for patients receiving docetaxel:

  18. Patients willing to receive docetaxel
  19. Neutrophil ≥ 1500 cells/mm3
  20. Liver function: AST and ALT ≤ 1.5 x ULN; ALP ≤ 2.5 x ULN; Serum bilirubin ≤ 1.5 x ULN.
  21. Male patients who will receive docetaxel and have partners of childbearing potential and/or pregnant partners are advised to use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 6 months after the last dose of docetaxel.

Exclusion Criteria:

  1. Patients with previous local treatment directed to the prostate primary cancer. A previous TURP is allowed,
  2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
  3. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily,
  4. Active infection or other medical condition for which corticosteroid use would be contraindicated,
  5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
  6. Prior systemic treatment with an azole drug within 4 weeks of randomization,
  7. Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg),
  8. Patients with a history of hypertension except if blood pressure is controlled by anti-hypertensive treatment,
  9. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
  10. History of pituitary or adrenal dysfunction,
  11. Small cell carcinoma of the prostate,
  12. Clinically known significant heart disease (myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina,NYHA Class II-IV heart disease or cardiac EF < 50% at baseline,
  13. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
  14. Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
  15. Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
  16. Administration of an investigational therapeutic within 30 days of D1,
  17. Patients already included in another therapeutic trial involving an experimental drug,
  18. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering participation,
  19. Individual deprived of liberty or placed under the authority of a tutor.

Additional criteria for patients receiving docetaxel:

21. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case of Cystoid Macular Oeadema, the patient should not receive docetaxel.

22. Concomitant use of strong CYP3A4 inhibitors ( clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin) 23. Allergy to taxane

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957436


Contacts
Contact: Beata JUZYNA b-juzyna@unicancer.fr
Contact: Claire JOUFFROY c-jouffroy@unicancer.fr

  Show 66 Study Locations
Sponsors and Collaborators
UNICANCER
Janssen-Cilag Ltd.
European Organisation for Research and Treatment of Cancer - EORTC
Ipsen
Investigators
Study Chair: Karim FIZAZI, Professor Gustave Roussy, Cancer Campus Grand Paris - Paris
  More Information

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01957436     History of Changes
Other Study ID Numbers: UC-0160/1105 GETUG AFU-21
First Submitted: September 24, 2013
First Posted: October 8, 2013
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by UNICANCER:
prostate
cancer
metastatic hormone-naive
radiotherapy
abiraterone acetate

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Prednisone
Abiraterone Acetate
Hormones
Androgens
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors