Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases
Recruiting
Phase 3
Interventional Study
Prostate Cancer
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 120
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 152 (estimated)
- Sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Other
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About This Trial
Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. . Newly diagnosed, histologically confirmed prostate adenocarcinoma
2. ≥ 18 years old.
3. Initial staging with Pelvic MRI, body CT-scan/bone scan or Choline or PSMA PET-CT
4. Any T stage
5. N stage: N1 - Pelvis lymph nodes metastases (upper limit defined as the L4/L5 interspa…
Contacts