Prostate AdenocarcinomaPhase 1Biolen-PCNCT04284761
A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
A Phase 1 study testing Bicalutamide implant in people with Prostate Adenocarcinoma and Lower Urinary Tract Symptoms, run by Alessa Therapeutics Inc. at 4 sites in 3 countries.
Trial summary
Biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether the Biolen is safe. Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Lower Urinary Tract Symptoms
- What is being tested?
- Bicalutamide implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 11 Oct 2020to 3 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate.
- Study participant qualified and planning for radical prostatectomy.
- At least 1 prostate lesion measurable by MRI > 0.5 cm within one month of screening.
- PSA > 3 ng/mL within 3 months of screening.
- Gleason score 3+4 or higher.
- Study participant must be willing to undergo post-treatment imaging by MRI.
- ECOG performance status 0 or 1.
Who cannot join
- Prior radiotherapy or surgery for prostate cancer.
- Prior or ongoing hormonal therapy for prostate cancer.
- Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure.
- Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
- Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
- Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of > 3 months.
Show all 10Show fewer
- Presence of any metastatic disease.
- Prostate volume more than 80 cc at prior MRI imaging.
- I-PSS score >20.
- History of prostate infection.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Australia2 sites
Australian Clinical Trials
Wahroonga, New South Wales, 2076
University of Wollongong
Wollongong, New South Wales, 2500
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether the Biolen is safe.
Read the detailed description
This prospective, multi-center, single-arm feasibility study is planned to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate in patients presenting for treatment of prostate cancer. Study participants will have placement of the drug eluting Biolen and be followed through scheduled radical prostatectomy.
- Being tested
- Bicalutamide implant
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicalutamide implantCombination product
Biolen bicalutamide implant
| Study group | Role | What they receive |
|---|---|---|
| Biolen | Experimental | Biolen bicalutamide implant. Single implantation. In situ until prostatectomy Receives: Combination Product: Bicalutamide implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by number and incidence of adverse events
Adverse Events
Measured: change from baseline to radical prostatectomy up to 12 weeks after implantation
Secondary outcomes (3)
change in prostate size
prostate measurement by MRI
Measured: change from baseline to radical prostatectomy up to 12 weeks after implantation
change in tumor size
tumor measurement by MRI
Measured: change from baseline to radical prostatectomy up to 12 weeks after implantation
change in Prostate Specific Antigen (PSA)
PSA level
Measured: change from baseline to radical prostatectomy up to 12 weeks after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start11 Oct 2020
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Biolen bicalutamide implant
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alessa Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Munster, MD, Study director, Alessa Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284761
- Sponsor's protocol ID
- CP-001
- Acronym
- Biolen-PC
- Status last verified
- Aug 2023
- First submitted
- 12 Feb 2020
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04284761
- Acronym / sponsor ID
- Biolen-PC / CP-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alessa Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biolen, a novel implant, is intended to deliver an anti-androgen locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether the Biolen is safe.
Detailed description
This prospective, multi-center, single-arm feasibility study is planned to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate in patients presenting for treatment of prostate cancer. Study participants will have placement of the drug eluting Biolen and be followed through scheduled radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biolen bicalutamide implant
| Arm | Type | Receives |
|---|---|---|
| Biolen | Experimental | Combination Product: Bicalutamide implantBiolen bicalutamide implant. Single implantation. In situ until prostatectomy |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the prostate.
- Study participant qualified and planning for radical prostatectomy.
- At least 1 prostate lesion measurable by MRI > 0.5 cm within one month of screening.
- PSA > 3 ng/mL within 3 months of screening.
- Gleason score 3+4 or higher.
Key exclusion criteria (10 listed)
- Prior radiotherapy or surgery for prostate cancer.
- Prior or ongoing hormonal therapy for prostate cancer.
- Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure.
- Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
- Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicalutamide implantBiolen bicalutamide implant | Combination product | Biolen |
Primary outcome
Safety as measured by number and incidence of adverse events
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
Adverse Events
3 secondary outcomes
change in prostate size
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
change in tumor size
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
change in Prostate Specific Antigen (PSA)
Time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Munster, MD study director
Alessa Therapeutics Inc.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bicalutamide implant in people with Prostate Adenocarcinoma and Lower Urinary Tract Symptoms, run by Alessa Therapeutics Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by number and incidence of adverse events (time frame: change from baseline to radical prostatectomy up to 12 weeks after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.