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 Hormone-Sensitive Prostate Cancer (mHSPC)Metastatic Prostate CancerOligoprogressive metastatic castration-refractory prostate cancerProstate CancerProstate 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
A Randomised, Double‑Blind, Placebo‑Controlled, 2‑Cohort, Phase III Study of Saruparib Combined with Physician’s Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone‑Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA‑directed 177Lutetium‑Containing Therapy Without Disease Progression, and With Prostate‑Specific Antigen ≥ 0.2 ng/mL: EvoPAR Prostate‑05
Not yet recruitingCTIS2026-526275-38-00
Target: 176Updated: 2026-10-27