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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03230734
Other study ID # IRST185.04
Secondary ID 2016-004452-29
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2017
Est. completion date July 2025

Study information

Verified date May 2023
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni
Phone +390543739266
Email oriana.nanni@irst.emr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms: - Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of progression (the second step is optional according to clinical evolution of disease) - Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of progression (the second step is optional according to clinical evolution of disease).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Radium-223
Radium-223: administered at the dose of 55 kBq per kg body weight, given at 4 week intervals for 6 injections, by slow intravenous injection
Docetaxel
Docetaxel: administered at the dose of 75 mg/m2 by intravenous infusion over a period of 1 hour every 3 weeks for 10 cycles. It is associated with prednisone 5 mg orally twice daily administered continuously.

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Sponsors (2)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary health-related quality of life (HRQoL) clinical benefit HRQoL clinical benefit, according to the Functional Assessment of Cancer Therapy-Prostate (FACT-P) up to 36 months
Primary health-related quality of life (HRQoL ) clinical benefit HRQoL clinical benefit, according to Brief Pain Inventory-Short Form questionnaire (BPI) for bone pain intensity. up to 36 months
Secondary Progression-free survival (PFS) PFS defined as the duration of time from randomization to time of progression or death, whichever occurred earlier up to 36 months
Secondary Total progression-free survival (TPFS) TPFS defined as total PFS at the end of the therapeutic sequence up to 36 months
Secondary Overall survival (OS) OS defined as the time from randomization to the date of death due to any cause or the last date the patient was known to be alive up to 36 months
Secondary toxic effects categorization for safety monitoring evaluation of toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 up to 36 months
Secondary Identification of markers predictive to clinical outcome Identification of markers predictive to clinical outcome including:
translational studies of circulating tumor DNA and/or circulating tumor cells and/or circulating RNA
serum chromogranin A and neuron specific enolase levels
positron emission tomography (PET) with choline and/or new tracer
up to 36 months
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