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Treatment of mCRPC with Ra223: response evaluation with 68Ga-PSMA PET. Phase II, non-randomized, multicentric, prospective study - CALIPSO

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: No

Linee di trattamento: Non applicabile

Criteri di inclusione: 

1. Age>45
2. Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigational nature of study
3. Histologically or cytologically confirmed adenocarcinoma of the prostate
4. Known hormone refractory disease (castrate serum testosterone level: ≤50 ng/dL)
5. Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 4 weeks
6. Bone pain (Brief Pain Inventory BPI-SF ≥ 2 )
7. ECOG Performance status (PS): 0-2
8. Acceptable haematology and serum biochemistry screening values as follows: WBC≥ 3000/mm3 , ANC≥ 1500/mm3, PLT≥ 100000/mm3 , Hb≥ 10 g/dl, Total bilirubin ≤ 2.0 mg/dL, ALT and AST ≤ 2.5 x the upper limit of normal, Serum creatinine <1.5 x the upper limit of normal

Criteri di esclusione: 

1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc) or to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc)
2. Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI
3. Visceral metastases assessed by thorax and abdominal/pelvic CT within previous 8 weeks
4. Malignant lymphoadenopathy exceeding 3 cm in short axis diameter assessed by thorax and abdominal/pelvic CT within previous 8 weeks
5. Patients with known inflammatory bowel disease (IBD)
6. Patients with known osteonecrosis of the jaw (ONJ)
7. Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug
8. Concomitant chemotherapy, abiraterone or enzalutamide therapy

Numero di pazienti previsti: 

50

Trattamento sperimentale: 

Patients with mCRPC, eligible to treatment with Ra223, will be evaluated with 68Ga-PSMA PET/CT imaging and will receive a single diagnostic dose of PSMA-11 labeled with up to 250 MBq/patient of 68Ga (2 MBq/kg) for each study. 68Ga-PSMA imaging PET will be performed at baseline, after 3 months and after 6 months (end of normal-regimen of treatment).

Trattamento di controllo: 

NA

Periodo previsto di arruolamento: 12 mesi

Centri partecipanti

Nord Italia

Osp. Regionale Valle d’Aosta Umberto Parini
Viale Ginevra 3 - 11100 Aosta - AO

Riferimento: Dr. Carlo Poti
Email: cpoti@ausl.vda.it

 

Ospedale di Bolzano
Via Lorenz Boehler 5 - 39100 Bolzano - BZ

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

 

AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
Ospedale Molinette

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NA

Data di inserimento: 25.02.2019

Data di aggiornamento: 02.10.2019

Promotore

Azienda USL Valle d'Aosta - SC Medicina Nucleare

CRO

/

Principal Investigator ITALIA

Riferimento: Dr. Carlo Poti

Telefono: 0165543311

Email: cpoti@ausl.vda.it

Localita: Aosta

 

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