CLINICAL TRIAL

TULSA Procedure for Prostate Cancer

Newly Diagnosed
Recruiting · 18+ · Male · Toronto, Canada

This study is evaluating whether a new surgery is as effective as a standard surgery for treating prostate cancer.

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About the trial for Prostate Cancer

Eligible Conditions
Prostate Cancer · Adenocarcinoma, Prostate · Prostatic Neoplasms

Treatment Groups

This trial involves 2 different treatments. TULSA Procedure 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
TULSA Procedure
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Radical Prostatectomy
DEVICE

Eligibility

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Prostate Cancer or one of the other 2 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male
People aged 45 to 80 years who are expected to live for more than 10 years. show original
A prostate biopsy has confirmed that the individual has prostate cancer, which is classified as either NCCN favourable or unfavourable intermediate-risk show original
The patient has stage ≤T2c, N0, M0 cancer. show original
Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy is defined as a Gleason score of 7 (3+4) or higher. show original
A PSA test result of ≤20ng/mL in the last three months is considered to be a negative result. show original
Treatment-naïve
The planned ablation volume is less than three centimeters from the urethra on an MRI acquired within the last six months. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
Screening: ~3 weeks
Treatment: Varies
Reporting: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether TULSA Procedure will improve 2 primary outcomes and 18 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Immediately after the procedure.

inpatient hospital stay endpoint
IMMEDIATELY AFTER THE PROCEDURE
Compare the length of inpatient stay between the two arms.
IMMEDIATELY AFTER THE PROCEDURE
Blood loss endpoint
DURING THE PROCEDURE AND IMMEDIATELY AFTER THE PROCEDURE
Compare the volume of blood lost between the two arms during treatment.
DURING THE PROCEDURE AND IMMEDIATELY AFTER THE PROCEDURE
Transfusion volume endpoint
DURING THE PROCEDURE AND IMMEDIATELY AFTER THE PROCEDURE
Compare the volume of transfused blood between the two arms during treatment.
DURING THE PROCEDURE AND IMMEDIATELY AFTER THE PROCEDURE
Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
12 MONTHS POST-TREATMENT
Compare preservation of urinary continence and erectile potency, between the 2 arms. Urinary continence is defined as 'pad-free' (0 pads/day) (per EPIC question 6) and erectile potency is defined as erection firmness sufficient for penetration (per IIEF question 2).
12 MONTHS POST-TREATMENT
Efficacy endpoint - proportion of patients free from treatment failure
36 MONTHS POST-TREATMENT
Compare the proportion of patients experiencing treatment failure, between the 2 arms. Treatment failure is defined as delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy), or metastatic disease, or prostate cancer-specific death.
36 MONTHS POST-TREATMENT
Histological failure endpoint
AT 12 MONTH POST TREATMENT, AND ALSO AT 24 MONTHS POST TREATMENT FOR PATIENTS WHO UNDERGO A REPEAT TULSA
Compare the proportion of patients who have clinically significant disease (defined as ISUP Grade Group 2 or higher) between the two arms.
AT 12 MONTH POST TREATMENT, AND ALSO AT 24 MONTHS POST TREATMENT FOR PATIENTS WHO UNDERGO A REPEAT TULSA
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Patient Q & A Section

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

Have there been any new discoveries for treating prostate cancer?

There have been many advances in treatments for prostate cancer. A variety of treatment options are available, including hormonal and chemotherapeutic approaches. There is also not yet a single preferred treatment option in which all patients can be treated successfully. Although prostate cancer remains an incurable disease, recent research has led to improvements in patient care.

Anonymous Patient Answer

How quickly does prostate cancer spread?

Men with Gleason 6-7 [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) have a higher chance of being treated with radical prostatectomy than men with Gleason 8-10 disease. From our data we conclude that there is little difference between the rates at which prostate cancer progresses in patients who are treated with radical prostatectomy vs. those who receive watchful waiting. However, when only patients with Gleason 9-10 disease are considered, patients with Gleason 8-9 disease have a significantly shorter time until recurrence than patients with Gleason 10-11 disease (p<0.01). This suggests that more aggressive treatment should be considered before radical prostatectomy rather than just watchful waiting when treating patients with Gleason 9-10 disease.

Anonymous Patient Answer

Does prostate cancer run in families?

A familial predisposition towards prostate cancer was demonstrated only among men who were diagnosed with prostate cancer <or =64 years before the onset of the first case; these results are consistent with the hypothesis that prostate cancers do not arise independently during lifetime. Further genetic factors might exist but must await confirmation in large population-based studies.

Anonymous Patient Answer

How serious can prostate cancer be?

The most serious complication of prostate cancer is BPH. Complications are more common among older men than younger ones but have less impact on survival. There is no clear relationship between the severity of complications and survival.

Anonymous Patient Answer

What is the primary cause of prostate cancer?

Men with RP generally have more than one motivation to seek treatment. Risk factors for prostate cancer are well known, but we did not find any strong indication of whether pathology was responsible for the occurrence of disease in most cases. We conclude that disease etiology is insignificant to prostate cancer pathogenesis, and that it cannot explain why some men develop the disease and others do not.

Anonymous Patient Answer

How does tulsa procedure work?

The data supports the theory that the procedure decreases the size and volume of the prostate, thus reducing the burden on the bladder neck and improving urine flow. This may be accomplished by relieving pressure on the urethra and relieving spasms of the muscles around the urethra.

Anonymous Patient Answer

Is tulsa procedure typically used in combination with any other treatments?

We found that tulsa surgery was typically combined with post-operative radiation therapy, chemotherapy, hormonal therapy, surgical ablation, laser vaporization, and cryosurgery. Recent findings are similar to those reported by others in the literature.

Anonymous Patient Answer

Have there been other clinical trials involving tulsa procedure?

Results from a recent clinical trial demonstrates that patients undergoing a tulsa procedure have a significantly higher chance of having positive (biopsy proven) prostate cancer than patients who receive a watchful waiting strategy. Results from a recent clinical trial support the need for more aggressive prostate cancer detection techniques to obtain a reliable cure rate when treating these patients.

Anonymous Patient Answer

What are the signs of prostate cancer?

A well-established medical history, physical examination, and laboratory tests are essential components of the workup of men presenting with symptoms of lower urinary tract symptoms suggestive of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). These include a complete evaluation of the bladder, urethra, and penis for evidence of suspicious lesions and/or inflammation; measurement of serum PSA and DRE at time of presentation; testicular ultrasonography; and measurement of prostate-specific antigen (PSA) in the urine. DRE, especially a palpable abnormality, is the only potentially curable indicator of prostate cancer and should be performed. The American Urological Association recommends performing a digital rectal exam within 3 months of completion of PSA testing.

Anonymous Patient Answer

Who should consider clinical trials for prostate cancer?

Consideration of clinical trial eligibility criteria may improve enrollment rates in clinical trials. Most prostate cancer clinical trials are open to all eligible patients; however, some trials require that patients undergo prior counseling regarding possible treatment side effects. Results from a recent paper suggests that clinical trial eligibility criteria should include consideration of side effect concerns and overall health status.

Anonymous Patient Answer

What are the chances of developing prostate cancer?

Men with a first degree relative with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) have an increased risk of developing the disease themselves. The risk increases with number of affected relatives. This suggests that genetic factors play an important role in prostate development.

Anonymous Patient Answer
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