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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA151261 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRIs and PSA Blood Test | Experimental |
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device |
| ||
| PSA Blood Test |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between MRI Parameter at Visit 1 and Nadir PSA | Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA | 2 months after starting ADT (Visit 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between MRI Parameter at Visit 2 With Nadir PSA | Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA | 6 weeks after starting EBRT (Visit 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fiona Fennessy, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | All enrolled patients undergo PSA sampling and prostate MRI. No control arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MRIs and PSA Blood Test |
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Between MRI Parameter at Visit 1 and Nadir PSA | Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA | 12 patients enrolled. For one patient, data was not extracted from the MRI due to artifact. | Posted | Number | 95% Confidence Interval | correlation coefficient | 2 months after starting ADT (Visit 1) |
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During and immediately after the MRIs.
Adverse events included any serious events related to the MRI exam. Expected adverse events from MRI are not serious and include claustrophobia while in the MRI magnet, a warming sensation while in the MRI magnet, or infiltration of intravenous contrast in the subcutaneous tissues at the time of its administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | All enrolled patients undergo PSA sampling and prostate MRI. No control arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fiona Fennessy | Brigham and Women's Hospital/Dana-farber Cancer Institute | 617 632 4891 | ffennessy@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2016 | Feb 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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. |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| mean |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| baseline PSA | Mean | Standard Deviation | ng/ml |
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|
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| Secondary | Correlation Between MRI Parameter at Visit 2 With Nadir PSA | Pearson correlation coefficient between MRI parameters at visit 2 with nadir PSA | Posted | Number | 95% Confidence Interval | Pearson correlation coefficient | 6 weeks after starting EBRT (Visit 2) |
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |