Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief 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.
Interventions
DEVICEMRI
OTHERPSA 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.
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between MRI Parameter at Visit 1 and Nadir PSA | 2 months after starting ADT (Visit 1) | Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between MRI Parameter at Visit 2 With Nadir PSA | 6 weeks after starting EBRT (Visit 2) | Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRIs and PSA Blood Test * 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
MRI
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.
Androgen Deprivation Therapy (ADT): Patients will receive ADT as part of their standard clinical care, as determined by their clinician.
External Beam Radiation Therapy (EBRT): Patients will receive EBRT as part of their standard clinical care, as determined by their clinician. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | MRIs and PSA Blood Test |
|---|---|
| Age, Continuous | 70.2 mean STANDARD_DEVIATION 6.6 |
| baseline PSA | 24.75 ng/ml STANDARD_DEVIATION 32.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Correlation Between MRI Parameter at Visit 1 and Nadir PSA
Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
Time frame: 2 months after starting ADT (Visit 1)
Population: 12 patients enrolled. For one patient, data was not extracted from the MRI due to artifact.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Correlation Between MRI Parameter at Visit 1 and Nadir PSA | -0.53 correlation coefficient |
p-value: 0.0995% CI: [-86, 0.1]Pearson's product-moment correlation
Secondary
Correlation Between MRI Parameter at Visit 2 With Nadir PSA
Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA
Time frame: 6 weeks after starting EBRT (Visit 2)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Correlation Between MRI Parameter at Visit 2 With Nadir PSA | -0.62 Pearson correlation coefficient |
p-value: 0.0395% CI: [-0.62, -0.15]Pearson's product-moment correlation