NUBEQA 300 mg film-coated tablets
Sponsors
UZ Leuven, Friedrich-Schiller-Universitaet Jena, AstraZeneca AB, Karolinska Institutet, Unicancer
Conditions
Castrate-resistant prostate cancer with oligometastases on functional imaging (PSMA or choline/fluciclovine-positron-emission tomography).High-risk localized or locally advanced prostate adenocarcinomaMetastatic Castration-Sensitive Prostate Cancer (mCSPC)Metastatic Prostate CancerOligoprogressive metastatic castration-refractory prostate cancerProstate CancerProstate cancerTriple-negative androgen receptor positive (molecular apocrine-like HER2-negative subtype) locally recurrent (unresectable) or metastatic breast cancer.
Phase 1
A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination with New Hormonal Agents in Patients with Metastatic Prostate Cancer (PETRANHA)
Active, not recruitingCTIS2023-508536-64-00
Start: 2022-05-17Target: 50Updated: 2025-04-28
Clinical Application of the Androgen Receptor Inhibitor Darolutamide to Upregulate the Prostate-Specific Membrane Antigen (PSMA) Protein Expression in Patients with Hormone Sensitive Prostate Cancer.
- The DARO-flare Trial -
Not yet recruitingCTIS2025-520482-52-03
Target: 16Updated: 2025-12-04
Phase 2
START : A randomized phase 2 study in patients with triple-negative, androgen receptor positive locally recurrent (unresectable) or metastatic breast cancer treated with darolutamide or capecitabine
Active, not recruitingCTIS2024-516638-36-00
Start: 2018-03-14Target: 1Updated: 2024-08-27
A randomized phase II trial of docetaxel or cabazitaxel with or without darolutamide in men with metastatic castration-resistant prostate cancer.
Not yet recruitingCTIS2024-516939-28-00
Target: 245Updated: 2025-12-03
Prostate Androgen Response Investigation using a Stratification BIOmarker - PARIS-BIO
Predicting prostate cancer downstageing by neoadjuvant Darolutamide with PCAI ImmunoScore in a non-randomised open label prospective trial.
RecruitingCTIS2025-520639-17-00
Start: 2025-11-12Target: 100Updated: 2025-06-19
Phase 3
Metastasis-directed therapy in oligoprogressive castration-refractory prostate cancer: a randomized phase 3 trial
RecruitingCTIS2022-502254-13-00
Start: 2023-12-18Target: 246Updated: 2025-07-18
A randomised, phase 3 trial comparing 3-weekly docetaxel 75 mg/m2 (in a 3 week cycle) versus 2-weekly Docetaxel 50 mg/m2 (in a 4 week cycle) in combination with Darolutamide + ADT in patients with metastatic hormone sensitive prostate cancer (mHSPC)
Active, not recruitingCTIS2022-502634-52-00
Start: 2023-05-16Target: 280Updated: 2025-08-25
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01).
RecruitingCTIS2023-504214-30-00
Start: 2024-06-27Target: 540Updated: 2025-11-13
PEACE 8: Combination of darolutamide and stereotactic body radiation therapy in patients with castration resistant prostate cancer and oligometastases on functional imaging.
RecruitingCTIS2023-507482-26-00
Start: 2024-10-04Target: 287Updated: 2025-10-02
ProBio: An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer
RecruitingCTIS2023-506857-40-00
Start: 2019-01-08Target: 1750Updated: 2025-12-15