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Prostate CancerPhase 3ARN-509NCT03488810

Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer

A Phase 3 study testing Radiation Therapy, Apalutamide and Luteinising Hormone Releasing Hormone analog agonist (LHRHa) in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main objective of the trial to determine if the combination of apalutamide with 6 months of androgen deprivation therapy by LHRH agonists in patients with intermediate and limited high-risk, localized prostate cancer receiving primary radiation therapy (RT) results in an improvement of disease-free survival (DFS)… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Radiation Therapy, Apalutamide and Luteinising Hormone Releasing Hormone analog agonist (LHRHa)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
10 Mar 2020to 15 Jun 2026
Phase
Phase 3
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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of prostate adenocarcinoma diagnosed by ultrasound guided biopsy of the prostate containing 10-12 cores showing no neuroendocrine component
  • Either of: Favorable intermediate risk (according to EAU risk groups): PSA 10-20 ng/mL, -or Gleason score 7 (3 +4) (ISUP Grade 2), or cT2b. Infavorable intermediate risk (according to EAU risk groups): PSA 10-20 ng/mL, -or Gleason score 7 (4+3) (ISUP Grade 3), or cT2b. Limited high risk : PSA > 20 ng/mL or Gleason score >7 (ISUP Grade 4/5)
  • M0 by standard imaging work-up
  • Scheduled to be treated with primary prostate RT
  • WHO Performance Status ≤ 2
  • No risk of urinary retention based on the International Prostate Symptom Score (IPSS) : IPSS < 20
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  • Adequate liver function determined by the following: aspartate aminotransferase (AST), alanine aminotransferase (ALT), < 2.5 x upper limit of normal (ULN). Total bilirubin <1.5 x upper limit of normal (ULN)
  • Adequate renal function: creatinine level < 2 x ULN
  • Serum albumin ≥ 3.0 g/dL
  • Serum potassium ≥ 3.5 mmol/L
  • Hemoglobin ≥ 10.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  • Platelet count ≥ 100,000 x 109/L independent of transfusion and/or growth factors within 3 months prior to randomization
  • Be able to swallow whole study drug tablets

Who cannot join

  • cT2c, T3, T4 or pelvic lymph nodes involvement, as assessed by CT scan or MRI (cN1) or pelvic lymph node dissection (pN1)
  • Previous pelvic irradiation or radical prostatectomy.
  • Bilateral orchiectomy
  • Prior systemic (e.g., chemotherapy) or procedural (e.g., prostatectomy, cryotherapy) treatment for prostate cancer
  • Prior treatment with 5-alpha reductase inhibitors for benign prostatic hypertrophy not discontinued 4 weeks prior to randomization
  • Prior treatment with any LHRH agonist or antagonist, bicalutamide, flutamide or nilutamide, enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer
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  • Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy for prostate cancer
  • Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years.
  • History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, systemic lupus erythematosus or Fanconi anemia
  • History of seizure or 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).
  • Medications known to lower the seizure thresholdmust be discontinued or substituted at least 4 weeks prior to study entry
  • Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g., heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval > 450 ms at baseline
  • Uncontrolled hypertension (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
  • Bilateral hip prostheses
  • 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 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
  • Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or LHRHa agonists or any of the components of the formulations
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

About this study

Official title: Radiotherapy and 6-month Androgen Deprivation Therapy With or Without Apalutamide in Intermediate and Limited High Risk Localized Prostate Cancer: a Phase III Study

The main objective of the trial to determine if the combination of apalutamide with 6 months of androgen deprivation therapy by LHRH agonists in patients with intermediate and limited high-risk, localized prostate cancer receiving primary radiation therapy (RT) results in an improvement of disease-free survival (DFS) evaluated by the treating physician, in comparison to the combination of radiation and androgen deprivation therapy without the addition of apalutamide.

Conditions
Prostate Cancer
Being tested
Radiation Therapy, Apalutamide, Luteinising Hormone Releasing Hormone analog agonist (LHRHa), Non-steroidal anti-androgen
Keywords
Apalutamide Prostate Cancer Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Radiation TherapyOther

    Dose escalated Intensity-Modulated Radiation therapy (IMRT) with conventional fractionation, hypofractionation and prostate brachytherapy are allowed.

  • ApalutamideDrug

    240 mg PO daily, started the same day as the first LHRHa injection, for 6 months

  • Luteinising Hormone Releasing Hormone analog agonist (LHRHa)Drug

    2 injections of a three-monthly LHRH agonist depot

  • Non-steroidal anti-androgenDrug

    Non-steroidal anti-androgen (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection

Study groups in NCT03488810
Study groupRoleWhat they receive
Arm A: ADT + radiation therapyActive comparatorPatient will receive 2 injections of a three-monthly LHRH agonist depot plus non-steroidal anti-androgen (rescue treatment) (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection. All patients will receive standard fractionation radiation therapy (RT) between 0 and 12 weeks after first injection of LHRH agonist.
Receives: Other: Radiation Therapy; Drug: Luteinising Hormone Releasing Hormone analog agonist (LHRHa); Drug: Non-steroidal anti-androgen
Arm B: ADT + radiation therapy + ApalutamideExperimentalPatients will receive 2 injections of a three-monthly LHRH agonist depot. Apalutamide treatment: 240 mg PO daily, started the same day as the first LHRHa injection, for 6 months. All patients will receive standard fractionation radiation therapy (RT) between 0 and 12 weeks after first injection of LHRH agonist.
Receives: Other: Radiation Therapy; Drug: Apalutamide; Drug: Luteinising Hormone Releasing Hormone analog agonist (LHRHa)

What is being measured

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

  1. Disease-free survival

    Events for this endpoint include loco-regional recurrence, distant metastases (radiologically or pathologically confirmed), death from any cause, whichever occurs first

    Measured: 7.8 years from First Patient In (FPI)

Secondary outcomes (9)

  1. Progression-free survival

    includes first events of biochemical failure by Phoenix criteria in addition to the events listed in the primary endpoint DFS

    Measured: 7.8 years from First Patient In (FPI)

  2. Distant Metastasis-free survival

    Measured: 7.8 years from First Patient In (FPI)

  3. Overall survival

    Measured: 7.8 years from First Patient In (FPI)

  4. Prostate cancer specific survival

    Measured: 7.8 years from First Patient In (FPI)

  5. Prostate-Specific Antigen (PSA) value

    Prostate-Specific Antigen (PSA) value will be assessed at the end of the treatment of each patient

    Measured: 5.5 years from First Patient In (FPI)

  6. Adverse events graded according to the National Cancer Institute Common Occurrence of Adverse Events

    Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 4.0

    Measured: 7.8 years from First Patient In (FPI)

  7. Health-related quality of life

    Health-related quality of life will be evaluated using self-administered EORTC QLQ-C30 questionnaire

    Measured: 7.8 years from First Patient In (FPI)

  8. Health-related quality of life

    Health-related quality of life will be evaluated using EORTC QLQ-PR25 instruments

    Measured: 7.8 years from First Patient In (FPI)

  9. Prostate-Specific Antigen (PSA) nadir

    Prostate-Specific Antigen (PSA) nadir will be assessed as the lowest value achievement on treatment

    Measured: 5.5 years from First Patient In (FPI)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start10 Mar 2020 (estimated)
  3. Primary completion15 Jun 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Why it stopped: Extended study timelines and additional budget could no longer be supported.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488810
Sponsor's protocol ID
EORTC-1531-ROG
Acronym
ARN-509
Status last verified
Aug 2020
First submitted
27 Mar 2018
Last updated
17 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiation Therapy, Apalutamide and Luteinising Hormone Releasing Hormone analog agonist (LHRHa) in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

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 13 inclusion and 20 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: withdrawn, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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?

Disease-free survival (time frame: 7.8 years from First Patient In (FPI)). 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 NCT03488810.

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 2020.

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