Clinical trial · Interventional
PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer
LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy
- 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 determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all 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 (2)
- measure
- Genitourinary and gastrointestinal toxicity 12 months post-treatment
- timeFrame
- Baseline to 1 year post-treatment
- description
- Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy
- measure
- Feasibility of meeting specified dose constraints
- timeFrame
- Baseline to 1 year post-treatment
- description
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 * Male subjects ≥ 18 years of age * Histologically confirmed prostate adenocarcinoma * Low or favorable intermediate risk, based on the NCCN criteria * 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 * Previous transurethral resection of the prostate (TURP) or surgery of the prostate
References
Publications (0)
Data not yet available