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21492 - A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol.
- Male ≥18 years of age at the time of signing the informed consent.
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit for (or refused) ART or SRT, or primary radiotherapy (RT).
- High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted).
- Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer.
- Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local assessment is allowed whenever central assessment cannot be done).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10^9/L.
- Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula.
- Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.

Criteri di esclusione: 

- Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate.
- History of bilateral orchiectomy.
- Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening.
- Brain metastasis on PSMA PET /CT by BICR at screening.
- High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy.

Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study.

- Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF.
- Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.
- Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks - prior to signing of the ICF.
- Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years.
- History of pelvic radiotherapy for other malignancy.

Trattamento sperimentale: 

Darolutamide + ADT

Trattamento di controllo: 

Placebo + ADT

Centri partecipanti

Nord Italia

Cliniche Humanitas Gavazzeni
Via Gavazzeni 21 - 24125 Bergamo - BG

 

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG
SC Oncologia

 

Azienda USL di Bologna, Ospedale Bellaria
Via Altura 3 - 40139 Bologna - BO
UOC Oncologia Interaziendale

 

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
UO Urologia

 

Azienda Ospedaliera S. Croce e Carle di Cuneo
Via Michele Coppino 26 - 12100 Cuneo - CN

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Divisione Urologia

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
SOC Oncologia Radioterapica

 

AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Arcispedale Santa Maria Nuova - Oncologia

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
UO Urologia

 

Presidio ospedaliero di Santa Chiara
Largo Medaglie d'Oro 1 - 38122 Trento - TN
UO Oncologia Medica

 

Ospedale di Castelfranco Veneto
Via dei Carpani 16 - 31033 Castelfranco Veneto - TV
Istituto Oncologico Veneto - UOC Urologia Oncologica

 

Centro Italia

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG
Ospedale Santa Maria della Misericordia - SC Radioterapia Oncologica

 

AOU Policlinico Tor Vergata
Viale Oxford 81 - 00133 Roma - RM
UOC Radioterapia

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Radioterapia oncologica

 

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
I.F.O. istituti Fisioterapici Ospitalieri - UO Urologia

 

Sud Italia e isole

AOU Ospedali Riuniti di Foggia
Viale Luigi Pinto 1 - 71121 Foggia - FG
U.O. Oncologia Medica e Terapia Biomolecolare

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
S.C. Oncologia Clinica Sperimentale Uro-Ginecologica

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-501343-33-00 - NCT05794906

Data di inserimento: 19.11.2024

Promotore

Bayer

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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