Early Changes In Multiparametric MRI In Prostate Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer|
- The primary aim of this study is to explore the feasibility of mpMR as an early imaging biomarker to assess response of intermediate- and high-risk prostate cancer during treatment with neoadjuvant ADT [ Time Frame: 2 month ] [ Designated as safety issue: No ]The primary endpoint of this study is whether mpMR parameters measured after 2 months of neoadjuvant ADT therapy (TP1) correlate with nadir PSA post 8-weeks of ADT. In addition, we will determine whether mpMR parameters in areas of tumor (T) in those who fail neoadjuvant ADT (defined as PSA end ADT values >.3 ng/ml) are different to those who respond to ADT (defined as PSA end ADT ≤.3ng/ml)
- A secondary aim is to explore the feasibility of mpMR as an imaging biomarker to assess response of bulky localized prostate cancer to combined ADT/EBRT. [ Time Frame: 4 months ] [ Designated as safety issue: No ]A secondary endpoint of this study is whether mpMR parameters measured after 6 weeks of EBRT (TP2) and 8 weeks after completion of EBRT (TP3) correlate with end PSA (defined as PSA level immediately after EBRT treatment). In addition, we will determine whether mpMR parameters in areas of T in those likely to fail combined ADT/EBRT (defined as PSA end values >.5ng/ml) are different to those of responders (PSA end values ≤.5ng/ml).
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: MRIs and PSA Blood Test
Other: PSA Blood Test
Serum 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01959542
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Fiona Fennessy, MD, PhD||Dana-Farber Cancer Institute|