Clinical trial · Interventional
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
NCT04176497CI-TRIAL-00098852terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.
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 |
|---|---|---|---|
| 68Ga-HBED-CC-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PMSA-PET/MRI
- description
- Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
- interventionNames
- Drug: 68Ga-HBED-CC-PSMA
Primary outcomes (1)
- measure
- Early Genitourinary and Gastrointestinal Toxicity
- timeFrame
- Up to 22 weeks (3 months after completion of radiation therapy)
- description
- Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Histologically confirmed prostate adenocarcinoma * Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol. * Subject has adequate performance status as defined by ECOG performance status of 0-2. * Subject is willing and able to comply with the protocol as determined by the Treating Investigator. * Subject speaks English (quality of life instrument is validated in English). Exclusion Criteria: * Contraindications for MRI * Other prior or concomitant malignancies with the exception of: * Non-melanoma skin cancer * Other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence. * Inflammatory bowel disease * Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects
References
Publications (0)
Data not yet available
No reference posted for this study.