Prostate CancerNCT05010759
Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for Intermediate-Risk Prostate Cancer
A study testing NanoTherm Ablation in people with Prostate Cancer, run by MagForce USA at 4 sites in United States.
Trial summary
Stage 2B: NanoTherm ablation of focal prostate cancer in small lesions in Gleason 3+4 disease. The outcome of this ablation is validated by a transperineal biopsy at 4 months after ablation. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- NanoTherm Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Nov 2021to 28 Jul 2023
- Phase
- Interventional
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 85
- Male
- Prostate adenocarcinoma on biopsy
- Clinical stage T1c/T2a/T2b, N0, M0/Mx with no lesion larger than 2cc in volume
- The following biopsy findings (biopsy must have MRI visualization and be within 6 months of planned NanoTherm® treatment):
- A positive biopsy for prostate cancer from the MRI-visualized lesion, at least one of which must be Gleason 3+4 (grade group 2)
Show all 9Show fewer
- Lesion must be visualized by Multiparametric Magnetic Resonance Imaging (MP-MRI) on a scan that is less than 6 months old
- Patient expresses a preference for active surveillance, rather than surgery or radiation, to manage prostate cancer
- Based on the evaluation of the study investigator, appropriate for instillation of NanoTherm® under anesthesia based on location and size of the clinical target volume (CTV)
Who cannot join
- Previous treatment for cancer with radiation, androgen deprivation (including LHRH-agonists or antagonists or antiandrogens), or surgery for prostate cancer
- Active urinary tract infection
- Metallic implants below the neck
- Gleason 3+4 or higher cancer on prostate biopsy outside of the planned CTV
- Gleason 4+3 or higher on any prostate biopsy
- Hematological abnormality indicating increased risk of bleeding or clotting, for example low platelet count or anemia
- Participation concurrently in another clinical trial for prostate disease or in the last 30 days
- Known hypersensitivity to Axumin®
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Urology Austin
Austin, Texas, 78759
MagForce - San Antonio
San Antonio, Texas, 78229
MagForce USA
Seattle, Washington, 98105
Florida Urology Partners
Tampa, Florida, 33615
About this study
Official title: Stage 2B of: A Pivotal, Prospective, Three-Stage, Single-Arm Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for a Limited-Volume, Clinically Localized, Intermediate-Risk Prostate Cancer
Stage 2B: NanoTherm ablation of focal prostate cancer in small lesions in Gleason 3+4 disease. The outcome of this ablation is validated by a transperineal biopsy at 4 months after ablation.
Read the detailed description
Presently, patients having intermediate-risk prostate carcinoma have to make a very difficult decision regarding treatment, as active surveillance will not immediately alter the current quality of life. However, because there is a risk of progressive disease or due to patient anxiety due to an untreated tumor, many patients opt for active treatment, often using radiation or prostatectomy, and sometimes in combination with androgen deprivation. Unfortunately, radiation, surgery, and androgen deprivation have multiple and potentially profound side effects including sexual, urinary, and bowel complications. As a small fraction of men dies from this disease, the number of men needed to treat to prevent one death is large, resulting in many men with side effects or complications to help prevent the one death. It is for these reasons that there is a major need for focal therapy for this group of patients who most commonly are treated actively with surgery or radiation; such focal therapy could ablate the detected tumor(s) within the prostate, control the disease while avoiding side effects of whole gland therapies and controlling tumor growth within the prostate detected by (multiparameter-) MRI and histopathologically confirmed by biopsy. MagForce NanoTherm® Therapy offers this option by noninvasive ablation of small tumors in a 1-2 ml target volume of the prostate, a treatment that is not possible with any other technology on the market.
This study evaluates the use of NanoTherm ablation as a method of treating these intermediate grade lesions allowing patients to return to active surveillance without definitive treatment such as external beam radiation or prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- NanoTherm Ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoTherm AblationDevice
Iron nanoparticles are instilled into the prostate cancer lesion and then the particles are heated using a magnetic field and this heating ablates the prostate cancer lesion.
| Study group | Role | What they receive |
|---|---|---|
| Ablation Arm | Experimental | Subjects in this arm of the study will have focal ablation of the prostate cancer lesion with the NanoTherm technology. This ablation will be followed-up transperineal prostate biopsy at 4 months after treatment. Receives: Device: NanoTherm Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Ablation Success
Rate of subjects with a biopsy confirmed ablation of prostate cancer lesion
Measured: 4 months (+/- 1 Month)
Secondary outcomes (1)
Adverse Event Rate
Rate of Adverse Events of Special Interest (AESI)
Measured: 4 months (+/- 1 Month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start30 Nov 2021
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Why it stopped: Inadequate enrollment and company changing direction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- MagForce USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Hammond, MS, Study director, MagForce USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010759
- Sponsor's protocol ID
- MGF-0115 - Stage 2B
- Status last verified
- Jul 2023
- First submitted
- 11 Aug 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage 2B of: A Pivotal, Prospective, Three-Stage, Single-Arm Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for a Limited-Volume, Clinically Localized, Intermediate-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05010759
- Acronym / sponsor ID
- MGF-0115 - Stage 2B
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment and company changing direction
- Enrolment
- 3 participants (actual)
- Lead sponsor
- MagForce USAIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 18 Aug 2021 (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.
Stage 2B: NanoTherm ablation of focal prostate cancer in small lesions in Gleason 3+4 disease. The outcome of this ablation is validated by a transperineal biopsy at 4 months after ablation.
Detailed description
Presently, patients having intermediate-risk prostate carcinoma have to make a very difficult decision regarding treatment, as active surveillance will not immediately alter the current quality of life. However, because there is a risk of progressive disease or due to patient anxiety due to an untreated tumor, many patients opt for active treatment, often using radiation or prostatectomy, and sometimes in combination with androgen deprivation. Unfortunately, radiation, surgery, and androgen deprivation have multiple and potentially profound side effects including sexual, urinary, and bowel complications. As a small fraction of men dies from this disease, the number of men needed to treat to prevent one death is large, resulting in many men with side effects or complications to help prevent the one death. It is for these reasons that there is a major need for focal therapy for this group of patients who most commonly are treated actively with surgery or radiation; such focal therapy could ablate the detected tumor(s) within the prostate, control the disease while avoiding side effects of whole gland therapies and controlling tumor growth within the prostate detected by (multiparameter-) MRI and histopathologically confirmed by biopsy. MagForce NanoTherm® Therapy offers this option by noninvasive ablation of small tumors in a 1-2 ml target volume of the prostate, a treatment that is not possible with any other technology on the market.
This study evaluates the use of NanoTherm ablation as a method of treating these intermediate grade lesions allowing patients to return to active surveillance without definitive treatment such as external beam radiation or prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation Arm | Experimental | Device: NanoTherm AblationSubjects in this arm of the study will have focal ablation of the prostate cancer lesion with the NanoTherm technology. This ablation will be followed-up transperineal prostate biopsy at 4 months after treatment. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 40 to 85
- Male
- Prostate adenocarcinoma on biopsy
- Clinical stage T1c/T2a/T2b, N0, M0/Mx with no lesion larger than 2cc in volume
- The following biopsy findings (biopsy must have MRI visualization and be within 6 months of planned NanoTherm® treatment):
Key exclusion criteria (8 listed)
- Previous treatment for cancer with radiation, androgen deprivation (including LHRH-agonists or antagonists or antiandrogens), or surgery for prostate cancer
- Active urinary tract infection
- Metallic implants below the neck
- Gleason 3+4 or higher cancer on prostate biopsy outside of the planned CTV
- Gleason 4+3 or higher on any prostate biopsy
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 |
|---|---|---|
| NanoTherm AblationIron nanoparticles are instilled into the prostate cancer lesion and then the particles are heated using a magnetic field and this heating ablates the prostate cancer lesion. | Device | Ablation Arm |
Primary outcome
Rate of Ablation Success
Time frame: 4 months (+/- 1 Month)
Rate of subjects with a biopsy confirmed ablation of prostate cancer lesion
1 secondary outcome
Adverse Event Rate
Time frame: 4 months (+/- 1 Month)
Results and safety
The study was stopped early (reason given: Inadequate enrollment and company changing direction). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
David Hammond, MS study director
MagForce USA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NanoTherm Ablation in people with Prostate Cancer, run by MagForce USA at 4 sites in United States.
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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Aug 2023. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment and company changing direction). Results are not available in the source record.
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?
Rate of Ablation Success (time frame: 4 months (+/- 1 Month)). 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 1 Aug 2023.