SAKK 08/23 – Addition of Darolutamide in the first-line treatment of metastatic hormone-resistant prostate cancer: a randomized phase II study

Switzerland (ICTRP)

ICTRP Studien-ID
NCT06401980 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
SAKK 08/23 Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial (BASEC)

Wissenschaftlicher Titel
Addition of Darolutamide to First Line Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): a Randomized Open Label Phase II Trial (ICTRP)

Öffentlicher Titel
Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (ICTRP)

Untersuchte Krankheit(en)
Metastatic Castration-resistant Prostate Cancer (ICTRP)

Untersuchte Intervention
Drug: Darolutamide;Other: Standard of care (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
Gender: Male
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:

- Written informed consent according to Swiss law and ICH GCP E6(R2) regulations
before registration and prior to any trial specific procedures

- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the
prostate

- Castration resistance: tumor progression after orchiectomy or during treatment with
GnRH analogues (agonists or antagonists).

- Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists
or antagonists) during the trial

- Metastatic disease, documented by imaging according to PCWG3 criteria

- Measurable disease or bone lesions that are evaluable according to PCWG3 criteria

- One line of previous ARPI therapy (abiraterone, enzalutamide, darolutamide,
apalutamide) for at least 18 months within mHSPC setting, showing an at least 50%
PSA response or partial remission according to RECIST v1.1

- Progressive disease according to PCWG3 before registration is defined as (at least 2
out of 3):

- PSA progression= 25% and = 2 ng/mL above nadir (2 consecutive rises at least 3
weeks apart)

- New metastatic lesion on imaging (at least two or more new bone lesions on bone
scan or one new non-bone lesion)

- Clinical progression

- Patients with a previously treated malignancy are eligible, when the risk of the
prior malignancy interfering with either safety or efficacy endpoints is very low

- Age = 18 years

- WHO performance status 0-2

- Adequate bone marrow function: absolute neutrophil count = 1.0 x 109/L, platelet
count = 100 x 109/L, hemoglobin = 90 g/L.

- Adequate hepatic function: total bilirubin = 1.5 x ULN (except for patients with
Gilbert's disease = 3.0 x ULN), ALT and AST = 2.5 x ULN, or = 5 x ULN under the
assumption that abnormal values are a result of cancer

- Adequate renal function: estimated glomerular filtration rate (eGFR) > 30
mL/min/1.73 m2 (according to CKD-EPI formula)

- Men agree not to donate sperm or to father a child during trial treatment and until
3 months after the last dose of trial treatment

- Patients are able and willing to swallow darolutamide as whole tablet.

Exclusion Criteria:

- Presence of a small cell component

- Prior systemic therapy for metastatic castration-resistant disease

- Prior chemotherapy for mHSPC, except docetaxel

- Prior LuPSMA or radium 223 for prostate cancer

- Concomitant or recent (within 28 days of registration) treatment with any other
experimental drug

- Concomitant use of other anti-cancer drugs or radiotherapy except for local pain
control and GnRH analogues

- Severe or uncontrolled cardiovascular disease

- Acute exacerbations of chronic illnesses, serious infections, or major surgery
within 28 days before expected start of treatment

- Clinical or radiological evidence of current spinal cord compression

- Any concomitant drugs contraindicated for use with darolutamide according to the
approved product information

- Known hypersensitivity to darolutamide

- Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI
absorption or tolerance of darolutamide

- Any other serious underlying medical, psychiatric, psychological, familial or
geographical condition, which in the judgment of the investigator may interfere with
the planned staging, treatment and follow-up, affect patient compliance or place the
patient at high risk from treatment-related complications. (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Radiographic progression-free survival (rPFS) (ICTRP)

Overall survival (OS);Time to symptomatic/clinical progression;Time to PSA progression;Event-free survival (EFS);Objective response rate according to RECIST;PSA response (30%, 50%, 90% and best);Duration of PSA response (50%) (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Richard Cathomas, Prof;Ursula Vogl, MD;Simone Rahel Wyss-Neyer, trials@sakk.ch, +41 31 389 91 91, Kantonsspital Graub?nden,Istituto Oncologico della Svizzera Italiana, (ICTRP)

Sekundäre IDs
SAKK 08/23 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06401980 (ICTRP)