Clinical trial · Interventional
Technetium Tc 99m Demobesin-4 for Imaging Procedures in Patients With Prostate Cancer
A Cancer Research UK Phase I Trial of 99mTc Demobesin-4 (a Diagnostic Radiopharmaceutical) Given Once Via Bolus Intravenous Injection for Imaging of 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)
RATIONALE: Diagnostic procedures, such as technetium Tc 99m demobesin-4 followed by single-photon emission computer tomography, CT scan, and MRI, may help find prostate cancer and learn the extent of disease. PURPOSE: This phase I trial is studying the side effects of technetium Tc 99m demobesin-4 and to see how well it works for imaging procedures in patients with prostate cancer.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| single photon emission computed tomography | Procedure | — | UNRESOLVED |
| technetium Tc 99m demobesin-4 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Causality of each adverse events as assessed by NCI CTCAE v. 3.0
- measure
- Biodistribution of radioactivity of 99mTc DB4 by gamma-camera imaging
- measure
- Pharmacokinetics of 99mTc DB4 in blood and urine and assessment of decline over 6 hours
Secondary outcomes (2)
- measure
- Performance of 99mTc DB4 gamma-camera imaging compared with conventional imaging (CT scan and/or MRI)
- measure
- Levels of expression in gastrin-releasing peptide in prostate tumor samples and lymph node specimens
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed prostate cancer meeting 1 of the following criteria:
* Disease confined to the prostate that is to be treated with radical prostatectomy after imaging
* Locally advanced disease that is to be treated with radiotherapy
* Patients must agree to undergo surgical pelvic lymph node staging to assist with determination of radiation fields
* Metastatic disease at initial diagnosis or recurrent or progressive disease
* Patients receive standard of care
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Neutrophils ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Serum creatinine ≤ 1.5 times ULN
* Must be registered with the Cancer Research UK Drug Development Office
* Capable of cooperating with imaging procedure and follow-up
* Fertile patients must use effective contraception during and for 6 months after completion of study therapy
* Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection
* No history of recent significant cardiac arrhythmia
* No prior NYHA class III-IV cardiac disease or concurrent congestive heart failure
* No other condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No chemotherapy or radiotherapy prior to or within 2 weeks of study therapy
* No prior major thoracic and/or abdominal surgery from which the patient has not yet recovered
* No other concurrent investigational drugs
* Concurrent anticancer therapy allowedReferences
Publications (0)
Data not yet available