The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI
Primary
· 1 scan
| Group | Value | 95% CI |
|---|---|---|
| Metastatic Prostate Cancer Arm | 3 |
Last reviewed · How we verify
NCT04086966
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Completed
Phase 1
Results posted
Last updated 26 April 2024
What this trial tests
Phase 1 trial testing [68Ga]PSMA-PET/MRI or PET/CT in Metastatic Prostate Cancer in 10 participants. Completed in 23 February 2022.
Timeline
20 August 2020
Primary endpoint
23 February 2022
23 February 2022
23 February 2022
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 10 |
| Start date | 20 August 2020 |
| Primary completion | 23 February 2022 |
| Estimated completion | 23 February 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- [68Ga]PSMA-PET/MRI or PET/CT — full drug profile →
Conditions studied
- Metastatic Prostate Cancer — all drugs for Metastatic Prostate Cancer →
Sponsor
University of Alabama at Birmingham
Who can join
18 and older, male only, with Metastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI
Secondary
· 1 scan
| Group | Value | 95% CI |
|---|---|---|
| Metastatic Prostate Cancer Arm | 19 |
Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered
Secondary
· 1 simulation scan
| Group | Value | 95% CI |
|---|---|---|
| Metastatic Prostate Cancer Arm | 8 |
Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities
Secondary
· 18 months
| Group | Value | 95% CI |
|---|---|---|
| Metastatic Prostate Cancer Arm | 0 |
The Total Number of Pelvic Nodal Metastases Detected on MRI
Secondary
· 1 scan
| Group | Value | 95% CI |
|---|---|---|
| Metastatic Prostate Cancer Arm | 9 |
Sponsor's own description
This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective.
Ng TSC, Gao X, Salari K, Zlatev DV, et al · · 2021 · cited 4× · PMID 34395293 · DOI 10.3389/fonc.2021.722277
Verify or expand the search:
- PubMed search for NCT04086966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Prostate Cancer
Currently open trials in the same condition.
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- NCT07389512 — Pharmaceutical Management in Targeted Radioligand Therapy · recruiting
- NCT07209176 — Physician- and Patient-based Barriers to NGS Testing · NA · recruiting
- NCT07181161 — Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer · Phase 1, PHASE2 · recruiting
Other University of Alabama at Birmingham trials
Trials by the same sponsor.
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- NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04086966 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 26 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04086966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing