A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

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))
    

Detailed 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.

      60 subjects will be enrolled.

      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®
      Depot equal 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.

      In Stage II, 40 subjects will be randomized to receive either 16mL (Cohort 3) or 20mL (Cohort
      4) of Liproca® Depot.

      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 treatment of Liproca® Depot.
      The dose will be injected into the tumour focus/foci and in close proximity to the tumour,
      based on a prostate biopsy (and MRI, if applicable), using a TRUS for guidance.

      Stage I subjects who received 35% volume of Liproca® Depot will receive 16 mL and subjects
      who received 45% volume of Liproca® Depot will receive 20 mL. Stage II subjects will receive
      the same dose of Liproca® Depot that was administered in the first treatment.

      Subjects in the OLE receiving a second injection will be followed up for an additional 24
      weeks for safety, tolerability and efficacy. After this period, subjects may undergo MRI
      imaging and a prostate biopsy.
    

Intervention name(s): 2-Hydroxyflutamide Depot
Intervention type(s): Drug
Intervention description(s): Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide
Other intervention name(s): Liproca® Depot Injection
Intervention MeSH terms: Hydroxyflutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Stage I: 20 Subjects will be enrolled into one of two groups, each receiving a single dose of Liproca®Depot. The target treatment dose will be 35% (Cohort 1) or 45% (Cohort 2) of the prostate volume (mL).
Stage II: 40 subjects will be randomized to receive either 16 mL (Cohort 3) or 20mL (Cohort 4) of Liproca®Depot.
Masking: Single (Participant)
Primary purpose: Treatment