Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluatio
- Conditions
- advanced castration resistant prostate cancer (CRPC)MedDRA version: 20.0Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002732-32-IT
- Lead Sponsor
- ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 210
1. Patients must have histologically or cytologically confirmed prostate cancer
2. Male, aged = 18 years.
3. Metastatic castration resistant prostate cancer
4. 68Ga-PSMA PET/CT positive in known site of disease, documented by CT or MRI or bone scan or 18Coline-PET
5. Patients with clinical progression from previous treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
1. Patients treated with chemotherapy and 223Ra radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy.
2. ECOG performance status >2
3. Assessed bone marrow invasion > 50%
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: is to evaluate the Disease Control Rate (DCR) and the safety ;Secondary Objective: late toxicity, Progression Free Survival (PFS), Overal Survival (OS), biochemical response and dosimetry;Primary end point(s): Disease Control Rate (DCR) and safety ;Timepoint(s) of evaluation of this end point: 46 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): dosimetry;Timepoint(s) of evaluation of this end point: 46 months