An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Pro... | Recruiting
An Efficacy and Safety Study of JNJ... | Recruiting
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

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Medical Conditions
  • Prostatic Neoplasms
Primary Contact Details
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See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02531516
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.
Research Details
  • This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus GnRH agonist compared with GnRH agonist among participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT). The study will include a Screening Phase, Treatment Phase, a Posttreatment Phase, and a Long-term Follow-up Phase. Participants will either receive either apalutamide (experimental) or bicalutamide 50 milligram (mg) capsule plus placebo as control group. Safety will be monitored throughout the study.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Apalutamide, Drug : Bicalutamide, Drug : Bicalutamide Placebo, Drug : Apalutamide Placebo, Drug : GnRH (agonist), Radiation : 74-80 Grays (units of radiation)

Study Arm Groups : Apalutamide, Control group, Apalutamide, Control group, Apalutamide, Control group, Apalutamide, Control group

Intervention Type
See Interventions above
Primary Outcome Measures
    Metastasis-free survival; 84 Months
Secondary Outcome Measures
    Time to Local-regional Recurrence; 84 Months; Time to Castration-resistant Prostate Cancer (CRPC); 84 Months; Time to Distant Metastasis; 84 Months; Overall Survival (OS); 84 Months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
1500
Participant Inclusion Criteria
    Inclusion Criteria:

    - Age >= 18 years

    - Indicated and planned to receive primary radiation therapy for prostate cancer

    - Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c

    - Charlson index (CCI) <=3

    - An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1

    - Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<) 1.5 milligram/deciliter (mg/dL) (<133 micromoles/Liter [mcmol/L]), (3) platelets greater than or equal to (>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 12.0 gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth factors within 3 months prior to randomization

    - Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial

    - Signed, written, informed consent

    - Be able to swallow whole study drug tablets

    Exclusion Criteria: -

    - Presence of distant metastasis, (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0.

    - Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization

    - Bilateral orchiectomy

    - History of pelvic radiation

    - Prior systemic (example [e.g.], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer

    - History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)

    - Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer

    - Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer

    - Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study

    - Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior to randomization

    - Use of any investigational agent <=4 weeks prior to randomization

    - Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral formulations

    - Major surgery <=4 weeks prior to randomization

    - Current or prior treatment with anti-epileptic medications for the treatment of seizures

    - Gastrointestinal conditions affecting absorption

    - Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations

    - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Rosemere Cancer Centre at Royal Preston Hospital
Fulwood
England
PR2 9HT
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Novartis Investigative Site
Wolverhampton
WV10 0QP
Derby
DE22 3NE
Bristol
BS2 8ED
Churchill Hospital
Oxford
OX3 7LE
Sheffield
S10 2SJ
Royal Blackburn Hospital
Blackburn
East Lancashire
BB2 3HH
NHS Grampian
Aberdeen
Scotland
AB25 2ZB
University Hospitals Birmingham
Birmingham
England
B15 2PR
Beatson West Of Scotland Cancer Centre
Glasgow
G84 7SSE
Derriford Hospital
Plymouth
PL6 8qh
Trial Contact(s)
Primary Trial Contact
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Belgium, Brazil, Canada, China, Czechia, France, Germany, Israel, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CR106935
Sponsor(s)
Aragon Pharmaceuticals, Inc.
Key Dates

Recruitment Start Date

Nov 2015

Recruitment End Date

Dec 2022

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

21 Aug 2015

Date updated in source

24 Aug 2017