NCT01959542

Early Changes In Multiparametric MRI In Prostate Cancer

Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	MRI
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-10-10
• Last updated: 2020-06-02
• Results posted: 2020-05-04

Locations

2 sites across 1 country: United States