NanoTherm Ablation for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MagForce USA, Sarasota, FL
Prostate Cancer+1 More
NanoTherm Ablation - Device
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a new treatment for prostate cancer can be used to treat small lesions in Gleason 3+3 and Clean 3+4 disease.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether NanoTherm Ablation will improve 2 primary outcomes and 1 secondary outcome in patients with Prostate Cancer. Measurement will happen over the course of 4 months (+/- 1 Month).

Month 4
Ablation Success
Adverse Event Rate
Rate of Ablation Success

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Ablation Arm
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. NanoTherm Ablation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Ablation Arm
Device
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months (+/- 1 month)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 months (+/- 1 month) for reporting.

Closest Location

MagForce USA - Sarasota, FL

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male
Prostate adenocarcinoma on biopsy
Clinical stage T1c/T2a/T2b, N0, M0/Mx with no lesion larger than 2cc in volume
A positive biopsy for prostate cancer from the MRI-visualized lesion, at least one of which must be Gleason 3+4 (grade group 2)
Lesion must be visualized by Multiparametric Magnetic Resonance Imaging (MP-MRI) on a scan that is less than 6 months old
Age 40 to 85
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)

Patient Q&A Section

Has nanotherm ablation proven to be more effective than a placebo?

"Results from a recent clinical trial shows that the presence of two large histologically confirmed cases of urethral involvement reduces the effectiveness of NANO ablative treatment of benign prostatic hyperplasia and the improvement produced by NANO ablative treatment does not persist after 2 yr and therefore cannot justify its use alone as a monotherapy." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nanotherm ablation?

"The study revealed that nanotherm ablation can be effective in eliminating small residual foci of prostate cancer cells. The method could potentially serve as a surgical adjunct to brachytherapy for treating insignificant prostate cancer." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nanotherm ablation?

"Recent findings suggest that nanotherm ablation can produce side effects similar to conventional TURP, but at a lower rate. Nanotherm ablation does not seem to bring about significant complications compared with standard TURP. Nevertheless, it should be considered only as a second line treatment to TURP in selected patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nanotherm ablation for therapeutic use?

"Currently, no clear data exist regarding the long-term efficacy and safety of RFA for treatment of locally [recurrent prostate cancer](https://www.withpower.com/clinical-trials/recurrent-prostate-cancer). Since the MRI-guided technique enables an accurate prediction of the area of necrosis, it could be considered as a safe and effective tool for the treatment of prostate cancer." - Anonymous Online Contributor

Unverified Answer

How does nanotherm ablation work?

"Nanotherm ablation created small temperature changes in the tissue at the ablation site without disrupting the normal cell cycle progression. The temperature change was sufficient to induce apoptosis of cells at the ablation site but not in the surrounding healthy tissue. We conclude that nanotherm ablation can be used effectively to destroy small areas of diseased tissue while leaving the rest of the tissue intact." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Symptoms are often vague, and many older men may first seek medical advice after noticing an abnormality on a PSA test result. A minority of men will suffer complications related to [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), including bone pain, erectile dysfunction, urinary urgency, and painful urination. Physicians must be aware that signs of prostate cancer can include a slow onset of symptoms, a family history of prostate cancer, abnormal enlargement of the prostate gland, redness around the base of the penis (a "patch test"), and lower back pain. All of these symptoms can point towards prostate cancer." - Anonymous Online Contributor

Unverified Answer

What does nanotherm ablation usually treat?

"The use of nanothermablation is currently limited by availability, high cost, and inadequate image quality. Data from a recent study demonstrates that using the CMR or MRgFUS technique enables accurate localization of small targets at low temperatures without destroying surrounding tissue. This new imaging modality has great potential for development into a clinically relevant tool for thermal treatment of a wide variety of solid tumors." - Anonymous Online Contributor

Unverified Answer

Does nanotherm ablation improve quality of life for those with prostate cancer?

"Nanotherm devices have significant effects on urinary continence and erectile function, as well as overall QoL in men with prostate cancer. These data provide the rationale for large multi-center clinical trials evaluating the use of nanotherm devices to treat men with localized prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostate cancer?

"There were 5,337 Pca diagnoses registered between January 2000 and December 2010. The mean age at first Pca diagnosis was 61 years. Men with more than one Pca tended to have earlier onset of the condition. In conclusion, Pca is rare in young men (<50 yr old). More studies are needed to determine the incidence of Pca in different age groups and the optimal age when it should begin screening programs." - Anonymous Online Contributor

Unverified Answer

Does prostate cancer run in families?

"Findings from a recent study suggest that the genetic predisposition to prostate cancer may be influenced by age at onset. This observation could have important implications for preventive medicine." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prostate cancer?

"Prostate cancer continues to represent a significant burden worldwide, especially in developed countries. A considerable amount of knowledge has emerged in recent years on the molecular pathways involved in genesis and progression of prostate cancer. This has led to the development of novel therapeutic approaches that have shown promising results in clinical trials. Treatment options are now expanding beyond hormone blockade and androgen deprivation therapy to include radiotherapy and targeted therapeutics." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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