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Multiparametric MRI After Radiotherapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Neelam Tyagi, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with biopsy proven (completed and/or reviewed at MSK) adenocarcinoma of the prostate, who will undergo external beam radiotherapy using conventional fractionation IGRT including moderate hypofractionated radiation, low rate brachytherapy alone, brachytherapy (either high dose or low dose) combined with supplemental image guided radiation (including IGRT, EBRT, and SBRT), SBRT, or proton radiotherapy.
Age ≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 months after completion of radiotherapy
Awards & highlights
Study Summary
This trial is testing if MRI can help manage prostate cancer treatment better and sooner for patients who have newly diagnosed prostate cancer.
Who is the study for?
This trial is for men over 18 with confirmed prostate adenocarcinoma, planning to undergo various forms of radiotherapy. They must have a visible tumor on MRI and can't have had hormone therapy in the last month. It's not for those with metallic pelvic implants, gadolinium contrast issues, metastatic disease, or conditions preventing MRI use like pacemakers.Check my eligibility
What is being tested?
The study uses advanced MRI techniques (MP-MRI and DCE) to monitor prostate cancer response after radiation treatments. The goal is to improve how doctors assess changes in the tumor post-therapy which could lead to better treatment management.See study design
What are the potential side effects?
Since this trial focuses on imaging rather than medication or invasive procedures, typical drug-related side effects are not expected. However, patients may experience discomfort from lying still during MRIs or anxiety if claustrophobic.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have prostate cancer confirmed by biopsy and will receive specific types of radiation therapy.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 24 months after completion of radiotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 months after completion of radiotherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
characterize the changes in tumor characteristics by functional imaging changes with post-treatment prostate biopsy outcomes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Multiparametric MRIExperimental Treatment3 Interventions
Patients undergo baseline standard (clinical) MP-MRI prior to therapy (ADT or RT). After completion of radiotherapy, follow-up MRIs will be obtained using the same 3T Philips MRI unit at approximately 3, 6, 12, 18 & 24 (+/- 4 weeks) months after radiotherapy. A standard post-tx biopsy will be performed at 24 months (+/- 4 weeks) after therapy which will serve to define the local control status after therapy. Local control based on this biopsy will be interpreted as negative or adenoca with severe tx effect; a positive biopsy will be a specimen which demonstrates adenocarcinoma that can be classified with a Gleason score as we have previously reported.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
biopsy
2002
Completed Phase 4
~8270
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,502 Total Patients Enrolled
132 Trials studying Prostate Cancer
51,954 Patients Enrolled for Prostate Cancer
Neelam Tyagi, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Michael Zelefsky, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
922 Total Patients Enrolled
8 Trials studying Prostate Cancer
615 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any metallic implants in my hip or pelvis that could affect MRI quality.I have prostate cancer confirmed by biopsy and will receive specific types of radiation therapy.I haven't had hormone therapy for cancer in the last month.I cannot have gadolinium contrast due to health reasons.I have had surgery to remove my prostate.I am 18 years old or older.My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Multiparametric MRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients who have yet to be enrolled in this clinical trial?
"The clinical trial in question, which was posted on December 1st 2014 and updated last on August 11th 2022, is not recruiting patients at this present time. However, there are many other medical studies currently looking for participants that patients may be interested in."
Answered by AI
Are there any dangers associated with MP-MRI that patients should be made aware of?
"There is some data suggesting that MP-MRI is safe, but none yet affirming its efficacy. Therefore, it received a 2 on our safety scale."
Answered by AI
In how many different geographical locations is this trial being run today?
"There 8 total locations where this trial is being conducted, including Memorial Sloan Kettering Nassau in Uniondale, Memoral Sloan Kettering Monmouth in Middletown, and Memorial Sloan Kettering Westchester in Harrison."
Answered by AI
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