Actively Recruiting

Phase 3
Age: 18Years - 120Years
MALE
NCT05116475

Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

Led by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Updated on 2024-03-12

152

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

A

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

What this Trial Is About

Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases

CONDITIONS

Official Title

Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

Who Can Participate

Age: 18Years - 120Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed, histologically confirmed prostate adenocarcinoma
  • Age 18 years or older
  • Initial staging with pelvic MRI, body CT-scan/bone scan, or Choline or PSMA PET-CT
  • Any T stage
  • N1 stage with pelvic lymph node metastases up to L4/L5 interspace
  • Planned long-term androgen deprivation therapy for 24 months
  • Hormonal therapy with LH-RH agonist or antagonist allowed up to 3 months before randomization
  • Able to receive protocol therapy with life expectancy at least 36 months and ECOG performance status 0-2
  • Blood counts at screening: hemoglobin ≥ 9.0 g/dl, neutrophils ≥ 1500/µl, platelets ≥ 100,000/µl (no growth factors or transfusions within 7 days prior)
  • Liver enzymes (ALT, AST) < 2.5 x ULN, total bilirubin < 1.5 x ULN (except Gilbert's disease), creatinine < 2.0 x ULN
  • Sexually active patients must agree to use condoms during treatment and for 3 months afterward unless surgically sterile
  • Written informed consent
  • Willing and expected to comply with follow-up schedule
  • Affiliated with social security system
  • Use of 5-alpha reductase inhibitors (finasteride, dutasteride) allowed
Not Eligible

You will not qualify if you...

  • Lymph node metastases outside the pelvis
  • Bone or visceral metastases
  • Prior systemic therapy for locally advanced prostate cancer except LH-RH agonist or antagonist up to 3 months before randomization
  • Prior treatment with second generation AR inhibitors (enzalutamide, apalutamide, darolutamide), CYP17 enzyme inhibitors (abiraterone acetate, TAK-700), oral ketoconazole, estrogens, or other AR inhibitors
  • Use of systemic corticosteroids > 10 mg prednisone/day within 28 days before randomization
  • QT or QTc interval > 450 ms on ECG
  • Initiation of bisphosphonate or denosumab treatment within 12 weeks before randomization (stable treatment ≥ 28 days allowed)
  • Known hypersensitivity to study treatments or ingredients
  • Major surgery within 28 days before randomization
  • Recent (within 6 months) serious cardiovascular events or severe heart failure
  • Uncontrolled hypertension with systolic BP > 160 mmHg or diastolic BP > 100 mmHg
  • Prior malignancy except certain treated skin or bladder cancers or other cancers disease-free > 5 years
  • Gastrointestinal disorders affecting absorption of study treatment
  • Active viral hepatitis, HIV, or chronic liver disease
  • Participation in another interventional clinical trial or concurrent investigational drug treatment
  • Conditions impairing ability to comply with study procedures
  • Unable to swallow study medications
  • Galactose intolerance, Lapp lactase deficiency, or glucose galactose-malabsorption
  • History of bilateral hip replacements preventing IMRT
  • Contraindications to any study treatment
  • Under guardianship or unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, France, 37170

Actively Recruiting

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Research Team

I

Ishak Senouci

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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