Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • enzalutamide

    Drug

    Localized single delivery of the Enolen implant (polymer + enzalutamide) with planned radical prostatectomy

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Enolen (tm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the adverse events associated with the Enolen implant

Using Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0).

Time frame
up to 12 months
2

Measurement of Pharmacokinetics Profile

Enzalutamide plasma (ng/ml), tissue levels (ng/gm) and optional seminal fluid levels (ng/ml)

Time frame
up to 12 months

Secondary outcomes

1

MRI changes

Prostate and tumor volume changes (mm3)

Time frame
up to 12 months post Enolen implantation
2

Changes in Prostate-specific antigen (PSA)

Measurements of the amount of PSA in the blood (ng/ml) at baseline through 6-12 weeks post radical prostatectomy

Time frame
6 to 12 weeks post radical prostatectomy
3

Changes in Testosterone

Measurements of testosterone levels in the blood (ng/dl) from baseline to radical prostatectomy

Time frame
6 to 12 weeks post Enolen implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alessa Therapeutics Inc.

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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