Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
ConditionProstate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age21+
SponsorAlessa Therapeutics Inc.
About this trial
The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.
Eligibility criteria
Qualifiers
Age at least 21 years old
Histologically confirmed adenocarcinoma of the prostate
Study participant qualified and planning for radical prostatectomy
At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
Disqualifiers
Prior radiotherapy or surgery for prostate cancer
Ongoing hormonal therapy for prostate cancer or hormone therapy <3 months prior to the start of treatment
Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive Benign Prostate Hyperplasia (BPH) procedure
Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
Trial design
Treatments tested in this trial
- enzalutamide
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Alessa Therapeutics Inc.
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov