Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) (LU-PSMA)
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|ClinicalTrials.gov Identifier: NCT03454750|
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration Resistant Prostate Cancer 68Ga-PSMA PET/CT Positive||Drug: 177Lu-PSMA||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC): Efficacy and Toxicity Evaluation|
|Actual Study Start Date :||April 19, 2017|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
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 ) [ Time Frame: up to 36 months ]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).
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 30 days after the last treatment cycle ]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.
- Progression free survival (PFS) [ Time Frame: up to 36 months ]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.
- Overall survival (OS) [ Time Frame: up to 36 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454750
|Contact: Oriana Nannifirstname.lastname@example.org|
|Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)||Recruiting|
|Meldola, FC, Italy, 47014|
|Contact: Giovanni Paganelli, MD 0543739100 email@example.com|
|Sub-Investigator: Ugo De Giorgi, MD|
|Study Chair:||Giovanni Paganelli||IRST IRCCS|