Multiparametric MRI for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MA
Prostate Cancer+1 More
Multiparametric MRI - Device
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Multiparametric MRI will improve 3 primary outcomes and 10 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of From baseline biopsy to final biopsy, up to 18 months.

2 Years
Number of participants to report a change in their health status following the MP-erMRI and rebiopsy o
2 years
Number of men who have an MP-erMRIs which appear to reclassify them to more extensive or aggressive disease
Number of participants who have an MP-erMRI finding suggestive of more aggressive disease relative to repeat 12 core TRUS biopsy
Report on the tumor grade and extent from the targeted biopsy relative to findings on the MP-erMRI
Month 18
Frequency of Reclassification
Median Change in Illness-Related Uncertainty, Anxiety, and Distress
Median Change in Prostate Cancer Symptoms
Median Change in Service Satisfaction
Median Change in Urinary Symptoms
Month 18
Disease Extent by Classification Status
Gleason Score by Classification Status
MP- erMRI Classification Specificity
MP-erMRI Classification Sensitivity

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Accuracy of multi-parametric MRI relative to prostate biopsy
1 of 1
Experimental Treatment

This trial requires 101 total participants across 1 different treatment group

This trial involves a single treatment. Multiparametric MRI 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.

Accuracy of multi-parametric MRI relative to prostate biopsyDetermine the sensitivity and specificity of MP-erMRI relative to repeat 12 core TRUS biopsy for classifying upgrading of disease extent or Gleason grade in men considering AS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prostate biopsy
2016
N/A
~560

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
N. M.
Neil Martin, MD
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Prostate Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the DF/HCC associated hospitals
Gleason ≤3+3
No tertiary Gleason grade ≥4
≤3 total cores positive
≤50% of any given core involved with cancer
No evidence on biopsy of extracapsular extension
PSA within one month of enrollment: <10 ng/mL
Clinical stage: ≤T2a & N0 or NX & M0
The subject is able and willing to abide by the study protocol or cooperate fully with the investigator or designee
The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document

Patient Q&A Section

What are common treatments for prostate cancer?

"It is essential to select the most appropriate therapy for each patient and to evaluate PSA level response to different treatment modalities. The optimal therapeutic approach for prostate cancer depends on a better understanding of the molecular biology of tumor progression and prognosis." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"The 5 %, 10 % and 50 % cure rates may be too high and should be confirmed in randomized controlled trials. No cure for prostate cancer exists in the foreseeable future. Nevertheless, a cure is not impossible." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"Age is the predominant risk factor for prostate cancer. Preventive measures can reduce prostate cancer risk to a smaller scope and at comparatively low cost. It is not known what causes prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"Men with prostate cancer often develop erectile dysfunction (ED) and/or impotence, even long after treatment. ED is not a specific symptom of prostate cancer, and ED frequently occurs in men without prostate cancer. Prostate cancer does not seem to cause or worsen ED. Treatment with androgen deprivation therapy is correlated with the risk of developing ED. Androgen deprivation therapy is associated with increased rates of bone loss, which can lead to fractures. Patients with prostate cancer and bone metastases are at an increased risk of fracture. In patients treated with androgen deprivation therapy, testosterone supplementation may decrease the risk of fractures." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Signs of prostate cancer may be present and/or symptomatic before a diagnosis of prostate cancer is obtained. Symptoms of metastatic disease include bone pain, pelvic pain, pain or lump in the pelvis, and pain or lump in the thighs, groin, shoulders or down to the knees." - Anonymous Online Contributor

Unverified Answer

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

"The US has a relatively low rate of prostate cancer incidence, while mortality is relatively high. The reasons for this finding are the result of early detection and high quality treatment, as well as lifestyle factors such as smoking and obesity." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for prostate cancer?

"The 5-year survival rate for prostate cancer patients was 92.3%; patients diagnosed less than 65 years of age were at higher risk for prostate cancer. The survival rate at 5 years for patients who were diagnosed between the ages of 55 and 65 years is 89.7%." - Anonymous Online Contributor

Unverified Answer

What is prostate biopsy?

"Prostate biopsy has a role in detecting [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) during prostate specific antigen screening. In particular, a random biopsy may be recommended whenever one or both sides are involved with cancer as long as this is not related to the patient specific characteristics. However in selected cases the detection of cancer at initial biopsy may change the treatment choice." - Anonymous Online Contributor

Unverified Answer

How serious can prostate cancer be?

"• Men with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are at a significant risk of mortality due to cardiovascular disease. • The rate of prostate cancer death in the Australian state of Victoria is low compared with other developed and developing countries, possibly reflecting its seriousness. • Men with localized prostate cancer at a high risk of dying are likely to be diagnosed later than men with less serious disease. • In Australia, most men under 50 years are diagnosed with localized prostate cancer. • A significant proportion of these men will require prostatectomy. • In Australia, death due to prostate cancer is only slightly increasing and is unlikely to continue to do so." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostate cancer?

"At this time it appears the lifetime odds for the presence of prostate cancer is about 1% while a prostate cancer death is about 9% depending on the age at which this disease occurs." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in prostate biopsy for therapeutic use?

"The number of patients who receive prostate biopsy in our region has doubled within the last 10 years. This phenomenon is due mainly to the use of multiparametric magnetic resonance imaging-ultrasound-guided biopsy with multiple cores taken from the peripheral zone of the prostate, followed by immediate pathological analysis with prostate-specific antigen measurement and prostate-specific antigen densitometry. This type of treatment is feasible and allows us to obtain more accurate pathological evaluation of focal prostate cancer." - Anonymous Online Contributor

Unverified Answer

Does prostate biopsy improve quality of life for those with prostate cancer?

"The PCa is a disease that can significantly impair QoL and has a significant impact on the psychological well-being of the patients with it. As patients with PCa are often younger and have a good prognosis. The study did not find that the prostate biopsy had any statistically significant beneficial effects on the QoL of these patients. In addition, there were no positive findings regarding sexual satisfaction in either group. The PCa should not be the sole determinant in the decision to have a prostate biopsy as part of standard care." - 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.
See if you qualify for this trial
Get access to this novel treatment for Prostate Cancer by sharing your contact details with the study coordinator.