NCT Number: NCT01959542
Early Changes In Multiparametric MRI In Prostate Cancer
In this research study, the investigators are trying to determine if there are measurable changes in prostate MRI that will help predict those who will or will not respond to Androgen Deprivation Therapy (ADT) and External Beam Radiation Therapy (EBRT) The first baseline prostate MRI prior to the start of treatment is standard of care. The participant's ADT/EBRT treatment is also standard of care, as advised by their doctor. It is the 3 follow up prostate MRIs during ADT/EBRT treatment, and 4 follow up serum PSA levels that are part of this research study.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
Brigham and Women's Hospital, Boston, Massachusetts, United States
About this study
If the participant chooses to take part in this research study, the participant will have 3 follow up prostate MRIs during a 6 month time period, while the participant is having their ADT/EBRT treatment. These follow-up prostate MRIs will use a standard imaging protocol without the use of an endorectal coil. The participant will also have a total of 4 blood samples to measure serum PSA. 1-2 mls (just less than ½ teaspoon) will be taken for each sample.
Research Study Plan
- Baseline Visit (routine standard of care screening visit): PSA blood test and prostate MRI
- Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI
- Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI
- Visit 3 (on last day of EBRT): PSA blood test
- Visit 4 (6 months after starting ADT): PSA blood test and prostate MRI
Planned Follow-up: The investigator would like to keep track of the participant's prostate cancer status while they continue to see their doctor at DFCI. The investigators would like to do this by collecting the following data from the participant's medical records, to look at long-term outcome of their ADT/EBRT treatment.
- PSA values
- Clinical results of your treatment. The investigator will not contact the participant to obtain this information.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult males with unfavorable intermediate- to high-risk localized disease, defined as having one of the following three categories, Clinical or radiographic T2b-T4 primary tumor or Gleason score 7-10 in any core, or PSA ≥ 10 prior to initiation of therapy
- Patients are deemed suitable for therapy with ADT and EBRT.
- Subjects must to able to provide informed written consent prior to study entry.
Exclusion criteria
- The standard exclusion criteria for MRI exams will apply which include patients with pacemakers, non-compatible intra-cranial vascular clips, inner ear implants, and severe claustrophobia.
- Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer are unlikely to be candidates for repeat MRIs, or cannot give valid informed consent.
- Patients unwilling or unable to undergo the multiparametric MRI exam (non-endorectal coil).
- Patients with a history of allergic reaction to latex or Gadolinium containing intravenous contrast agents.
- Individuals with renal disease or other contraindications to gadolinium will be excluded. The BWH standard MRI contrast screening criteria will be used to establish renal status.
- Patients who have had prior prostatectomy or prior androgen therapy.
- Patients with hip implant or any other metallic implant or device that results in significant distortion of the local magnetic field and compromise of the quality of the multiparametric MRI data.
Treatment and study plan
PSA Blood Test
OtherSerum PSA will also be subsequently checked on the same day as each follow-up MR is performed, i.e. TP 1, 2 and 3, and right after finishing EBRT. 1-2 mls of blood will be sampled per blood test.
Primary outcomes
-
Correlation Between MRI Parameter at Visit 1 and Nadir PSA
Time frame: 2 months after starting ADT (Visit 1)
Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
Secondary outcomes
-
Correlation Between MRI Parameter at Visit 2 With Nadir PSA
Time frame: 6 weeks after starting EBRT (Visit 2)
Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA
Sponsors and collaborators
Lead sponsor
Dana-Farber Cancer Institute
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer
Important dates
- Study start
- 2013
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Oct 10, 2013
- Registry last updated
- Jun 2, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Mobile Sensor Technologies to Assess General Symptomology of People With Cancer
NCT04465214
Colon Cancer, Colonic Diseases
Bethesda, Maryland, United States
View Trial DetailsThe Effect of Intrarectal Ice Application on Pain, Anxiety, Cortisol Level, Complication Development in Transrectal Ultrasonography Guided Prostate Biopsy
NCT06998121
Anxiety Disorders, Genital Diseases
Mersin, Turkey (Türkiye)
View Trial DetailsArtemiCoffee in Patients With Rising PSA
NCT05478239
Genital Diseases, Genital Diseases, Male
Lexington, Kentucky, United States
View Trial DetailsEffect of Rectus Block Timing on Opioid Use
NCT07433140
Agnosia, Genital Diseases
Istanbul, Turkey (Türkiye)
View Trial Details