Clinical trial · Interventional
Prostate MRI and Pylarify PSMA PET/CT
Monitoring Prostate Cancer Tumor Response to Radiation Therapy Using Advanced Functional Magnetic Resonance Imaging (MRI) and Pylarify (18F-DCFPyL) PSMA Positron Emission Tomography (PET)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study withdrawn due to lack of funding and resources
Summary
Brief summary (as posted)
This is a voluntary research study to find out how using technology including advanced magnetic resonance imaging (MRI) and prostate-specific membrane antigen - positron emission tomography (PSMA-PET) scan imaging, in addition to combined prostate treatment using radiation therapy, brachytherapy (internal radiation treatment using small radioactive seeds placed inside the body) and androgen deprivation therapy (drug therapy to suppress hormones) can help doctors see, track and predict tumor response to treatment for prostate cancer patients. Participation in this study will consist of radiation planning and simulation, magnetic resonance imaging (MRI) and positron emission tomography and computed tomography scan (PET/CT). One MRI and PSMA PET/CT scan will be done prior to the start of first external beam radiation therapy (EBRT) fraction. At mid-treatment prior to the second brachytherapy fraction, an MRI and PSMA PET/CT will be done. A third scan will be performed after 75% testosterone recovery or 12 months post androgen deprivation therapy (ADT) \[whichever comes first\].
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pylarify Piflufolastat Flourine-18 (18F-DCFPyL) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment MRIs and Pylarify PSMA PET/CTs
- description
- 2 MRIs and 2 Pylarify PSMA PET/CTs, occurring at mid-treatment and when testosterone level is 75% recovered or 12 months after androgen deprivation therapy (ADT), whichever comes first
- interventionNames
- Drug: Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)
Primary outcomes (4)
- measure
- Difference from baseline (pre-treatment) to mid-treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
- timeFrame
- From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment
- description
- Difference in the MRI imaging parameter Amide Proton Transfer (APT) weighted relative signal intensity between pretreatment scan and mid-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Planned definitive radiation for high-risk prostate cancer, radiotherapy plan to include high dose-rate (HDR) brachytherapy boost * High-risk prostate cancer (tumor stage cT3a-cT4, OR Grade Group 4 or 5, OR prostate-specific antigen (PSA) \>20 ng/mL) * Patients with clinically positive regional lymph nodes * Patient planned to receive at least 12 months of androgen deprivation therapy * Age ≥18 years * No maximum age cutoff, however must have life expectancy \> 5 years based on patient's overall health * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient able to have 3-Tesla (3T) MRI per Beaumont Radiation Oncology MRI safety questionnaire Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 3-5 * Metastatic disease * Prior androgen deprivation therapy before study enrollment * Prior radiation to pelvis * Prior malignancy not achieving remission or with prognosis \< 5 years * Synchronous malignancy confirmed or suspected * Any patient not suitable for brachytherapy * Severe claustrophobia precluding the acquisition of MRI * Unable to safely have 3T MRI * Cognitively impaired
References
Publications (0)
Data not yet available