| Title: |
Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP) |
| Authors: |
Morgans, Alicia K.; Chehrazi-Raffle, Alex; Niazi, Tamim; Shore, Neal D.; Ross, Ashley E.; Roder, Andreas; Gomes, Andrea Juliana; Supiot, Stephane; Barthelemy, Philippe; Hatano, Koji; Ruiz, Carmen Belen Congregado; Yoshida, Soichiro; Herrera-Imbroda, Bernardo; Gratton, Matthieu; Gschwend, Jurgen E.; Hope, Thomas A.; Joensuu, Heikki; Kuss, Iris; Le Berre, Marie-Aude; Dimova-Dobreva, Miryana; Fizazi, Karim |
| Contributors: |
Department of Oncology; Research Programs Unit; Heikki Joensuu / Principal Investigator; HUS Comprehensive Cancer Center |
| Publisher Information: |
Taylor and Francis Ltd. |
| Publication Year: |
2026 |
| Collection: |
Helsingfors Universitet: HELDA – Helsingin yliopiston digitaalinen arkisto |
| Subject Terms: |
Darolutamide; Psma pet/ct; Biochemical recurrence; Cancer imaging; Prostate cancer; Cancers |
| Description: |
Patients with prostate cancer treated with radiotherapy (RT) or radical prostatectomy (RP) as primary therapy may develop biochemical recurrence (BCR), which requires effective treatment to delay disease progression. The ARASTEP study (NCT05794906) aims to determine whether the addition of darolutamide to androgen-deprivation therapy (ADT) improves radiologic progression-free survival (rPFS) using prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) compared with placebo plus ADT in patients with high-risk BCR.Approximately 970 patients from 243 sites globally will receive either darolutamide 600 mg or placebo twice daily, both with ADT, for 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent. Eligible patients will have been treated by primary RT or RP +/- adjuvant RT (ART) or salvage RT (SRT), and present with high-risk BCR (prostate-specific antigen [PSA] doubling time = 0.2 ng/mL after RP [+/- ART/SRT] or PSA >= 2 ng/mL above nadir after primary RT only), >= 1 PSMA PET/CT-positive lesion (negative on conventional imaging), serum testosterone >150 ng/dL, and Eastern Cooperative Oncology Group performance status 0/1. The primary endpoint is rPFS using PSMA PET/CT, with secondary endpoints including metastasis-free survival, time to castration-resistant prostate cancer, overall survival, quality of life, and safety. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT05794906. PLAIN LANGUAGE SUMMARY Prostate cancer develops when prostate gland cells grow abnormally. This may be treated with surgery or radiotherapy. A hormone lowering therapy, called androgen-deprivation therapy (ADT), can also be used to lower testosterone levels to slow or stop cancer growth. Prostate-specific antigen (PSA) is an enzyme made by the prostate and can be found in the blood of people with and without prostate cancer. However, PSA levels are increased by prostate cancer. When patients with previously ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
This manuscript and the ARASTEP study were funded by Bayer.; https://hdl.handle.net/10138/625913; 105021657227; 001614258700001 |
| Availability: |
https://hdl.handle.net/10138/625913 |
| Rights: |
cc_by_nc_nd ; info:eu-repo/semantics/openAccess ; openAccess |
| Accession Number: |
edsbas.7E6CB696 |
| Database: |
BASE |