TULSA-PRO for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Prostate Cancer+1 More
TULSA-PRO - Device
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether TULSA-PRO will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 3, 6, 12, 18, 24, and 36 months.

Month 36
changes in imaging and biopsy characteristics
effect of thermal ablation on short- and long-term complication rates
feasibility and tolerability
outcome of TULSA ablation
safety and tolerability
thermal damage

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
1/Arm 1

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. TULSA-PRO 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.

1/Arm 1
Device
Ultrasound ablation of focal prostate cancer
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 12, 18, 24, and 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3, 6, 12, 18, 24, and 36 months for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Gleason Score <= 7;
<= 4 cores positive in a standard 12 core biopsy and <= 4 cores positive on MRI target lesions biopsy where 2 cores are taken from each of the one or two MRI target lesions;
histologically positive standard biopsy cores must be from the same location in the prostate as an MRI target lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex).
organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI imaging. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.
PSA < 20 ng/ml.
Adults (>= 18 years of age)
Platelets >= 50,000/mcL
Hemoglobin >= 8 g/dL
ALT or AST <= 5 x ULN
diagnosed by prostate biopsies consist of transrectal ultrasound-guided standard 12 core biopsy and biopsies of one or two MRI target lesions;

Patient Q&A Section

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

Can prostate cancer be cured?

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Patients with late-stage, advanced prostate cancer have a very poor prognosis. With current treatment, no cure is possible, but treatment reduces symptoms and improves quality of life. Treatment should be considered for patients with asymptomatic, early-stage disease.

Unverified Answer

What is prostate cancer?

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Prostate cancer is a cancer that forms in the prostate and typically appears in men over the age of 50. It is often identified by frequent, painful or bloody urination or painful ejaculation. PSA-based screening is considered reasonable for all men over 50 years of age, as the American College of Physicians/US Preventive Services Task Force. The use of age-based PSA screening remains controversial but may increase detection rates of asymptomatic disease and decrease mortality and morbidity from prostate cancer.

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What are the signs of prostate cancer?

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We hypothesise that certain signs could be related to [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). These signs, mainly related to high-grade cancers, will be discussed. The clinical signs are not conclusive to the diagnosis of prostate cancer, but they should be considered in the clinical evaluation of the patient.

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What are common treatments for prostate cancer?

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Treatment for prostate cancer is highly variable and depends on the severity, grade, stage and extent of the condition. Common options include surgery or radiation therapy. If radiation therapy is used it is typically provided by a radiobiologist specialist.

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What causes prostate cancer?

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There appears to be three main types of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) based on where they start: on the skin or lining of the urinary tract, at the opening of the body-prostate-skin junction, and inside the outer prostate. The number of genes that have been shown to be affected by prostate cancer varies depending on which form of the cancer is present, but the same genes probably cause prostate cancer in all forms of the disease. Most cancers that are detected at the start of the disease, and are potentially curable, are from early prostate cancer that has not spread inside healthy tissues. Prostate cancer is usually diagnosed by screening and by examining the blood in samples taken from the prostate by using a PSA level above 10 ng/mL.

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How many people get prostate cancer a year in the United States?

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Approximately 10.1 million men were diagnosed with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in 2006 in the United States. In 2006, 1.7 million men were newly diagnosed with prostate cancer and 2 million men were diagnosed with a localized prostate cancer recurrence. For most men diagnosed with prostate cancer, prostate specific antigen testing or biopsy was performed.

Unverified Answer

What does tulsa-pro usually treat?

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The data suggest the existence of a general belief that Tulsa-related practices are able to prevent many forms of illnesses, as well as treatments for such and a range of other conditions. While there may be a tendency to believe that the Tulusa Clinic is 'all about prostate cancer' it may not be entirely clear whether this has not been a consequence to the lack of clinical research. It is likely that both the belief and the practice are in fact a balance between religion and scientific medical thinking.

Unverified Answer

How does tulsa-pro work?

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Tulsa's prostate specific antigen (PSA) screening program was feasible, demonstrated acceptable patient acceptance, and resulted in the early identification of many patients with the potentially treatable prostate cancer.

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What are the chances of developing prostate cancer?

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Even in the presence of a prostate specific antigen (PSA) >4 ng/mL, age-specific rates of developing prostate cancer are rare. Thus, in the absence of other risk factors for prostate cancer in men without a prior diagnosis, PSA levels alone should not be used for counseling about the incidence of prostate cancer or for establishing an acceptable surveillance program. answer: Men without a prior diagnosis of prostate cancer may be considered for PSA only-based screening, but in these men, even men with a 4+ PSA result, prostate cancer has a prevalence that is only 10%, less than what would be expected from age-related rates alone.

Unverified Answer

What is tulsa-pro?

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The current technology for detection of early lesions has a fairly high sensitivity and specificity. The use of biochemical techniques alone may accurately identify patients who would receive a favorable treatment.

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Has tulsa-pro proven to be more effective than a placebo?

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The data indicate that Tulsa is an effective and safe treatment of advanced prostate cancer. Results from a recent paper show that Tulsa is superior to the placebo in its effectiveness, tolerability, and safety profile. Results from a recent paper demonstrates Tulsa to be a highly active alternative therapy for advanced prostate cancer with a relatively benign risk/benefit ratio.

Unverified Answer

Is tulsa-pro typically used in combination with any other treatments?

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Results from a recent clinical trial of this study suggest that TPS is primarily used in combination with other treatments rather than as a single treatment. However, the use of combination treatment as opposed to monotherapy treatment should be studied further.

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