Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
| PSA Blood Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRIs and PSA Blood Test
- description
- * 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
- interventionNames
- Device: MRI
- Other: PSA Blood Test
Primary outcomes (1)
- measure
- Correlation Between MRI Parameter at Visit 1 and Nadir PSA
- timeFrame
- 2 months after starting ADT (Visit 1)
- description
- Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
Secondary outcomes (1)
- measure
- Correlation Between MRI Parameter at Visit 2 With Nadir PSA
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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