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Clinical Trial Summary

A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))

Clinical Trial Description

Patients assigned to Active Surveillance and who have fulfilled all inclusion criteria will receive a prophylactic antibiotic and a local anaesthetic (according to the Investigator's Standard of Care) prior to administration of Liproca® Depot. The treatment dose will be dependent upon thesubject's prostate volume (mL).

50 to 60 subjects will be enrolled into one of three groups, each receiving a single dose of Liproca® Depot. The target treatment dose will be 35%, 45% or 50%* of the prostate volume(mL). If it is not possible to inject the target dose, the volume of the actual dose will be documented. All subjects will be followed for safety, efficacy (effect on PSA level and prostate volume), tolerability and pharmacokinetics (Cohort 1 and Cohort 2, and 10 to 20 subjects in Cohort 3) for up to 24 weeks after initial treatment.

The Single Dose Study will be conducted in two stages:

In Stage I, 20 subjects will be randomized into two groups to receive one dose of Liproca® Depotequal to 35% (Cohort 1) or 45 % (Cohort 2) of their prostate volume (mL) (N=10:10). Two weeks after all subjects have received their initial dose, the Data Safety Monitoring Board (DSMB) will review the subjects' safety and tolerability data over the first 14 days after receiving treatment. Based on the recommendation of the DSMB, the Sponsor will determine the dose of Liproca®Depot to be administered to subjects enrolled in Stage II (tentatively 50%* of prostate volume).

In Stage II, 30 to 40 subjects (Cohort 3) will receive one dose* of Liproca® Depot deemed safeand tolerable by the DSMB and the Sponsor. The DSMB will convene again to evaluate the safety and tolerability of this dose after inclusion of the first 10 subjects, using the first 14 days' safety and tolerability data. The Sponsor will adjust the dose, if necessary.

All subjects in Stage I and Stage II will be followed for 24 weeks. Subjects who complete the Single Dose Study and who experience no safety or tolerability issues, as determined by the Investigator, may be offered an option to participate in the Open Label Extension Study (OLE). Subjects enrolled in the OLE will be observed for PSA recurrence every 8 weeks. If PSA recurrence is confirmed (defined as a PSA level exceeding at least 100 % of Baseline value) subjects will receive a second dose of Liproca® Depot. This dose volume willbe the same as that received in the Single Dose Study.

Subjects in the OLE receiving a second injection will then be followed up for an additional 24 weeks for safety, tolerability and efficacy. After this period, subjects will undergo MRI imaging and a prostate biopsy. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03348527
Study type Interventional
Source CMX Research
Contact Nada Dragicevic
Phone 905-338-1078
Status Recruiting
Phase Phase 2
Start date May 12, 2017
Completion date May 2019

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