A Phase 2 interventional study of 177Lu-PSMA in Metastatic Castration Resistant Prostate Cancer and 68Ga-PSMA PET/CT Positive, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. Completed at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Phase 2, Interventional, and Treatment
Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation
Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation. Single-center, prospective, non controlled, open label, phase II trial. The main objective of this study is to evaluate the Disease Control Rate (DCR) and the safety as co-primary objective.
The secondary objectives are: late toxicity, PFS, OS, biochemical response and dosimetry.
Exclusion Criteria:
177Lu PSMA
Drug: 177Lu-PSMA
177Lu-PSMA 3.7-5-5 GBq Intravenous Slowly in 15-30 ' Day 1/ every 8-12 weeks Four cycles every 8-12 weeks
Disease Control Rate (DCR )
DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease lasting for at least 6 months from therapy start. DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: up to 36 months
Incidence of Treatment-Emergent Adverse Events
The evaluation of the Incidence of Treatment-Emergent Adverse Events starts from the 1st treatment until 30 days after the last treatment cycle; Treatment-Emergent Adverse Events are evaluated according to version 4.03 CTC-AE criteria.
Time frame: up to 30 days after the last treatment cycle
Progression free survival (PFS)
PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.
Time frame: up to 36 months
Overall survival (OS)
Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
Time frame: up to 36 months
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS