Clinical trial with Sarabesin 3, a GRP receptor antagonist, labelled with gallium-68, in patients with prostate cancer confined to the primary orga

• Conditions: prostate cancer; prostate carcinoma; 10038597; 10036958

• Registration Number: NL-OMON39894
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- male patients of 18 years and older;
- histologically confirmed prostate cancer, no clinical suspicion of
metastasis;
- patient is scheduled for radical prostatectomy;
- capable of cooperating with imaging procedure and follow-up;
- World Health Organisation (WHO) performance status 0-2;
- signed and dated informed consent.

Exclusion Criteria

- current severe and/or uncontrolled and/or unstable other medical
disease (e.g. poorly controlled diabetes, unstable and uncontrolled
hypertension, chronic renal or hepatic disease, severe pulmonary
disease);
- other known malignancies (except local skin cancer);
- chemotherapy, radiotherapy, or anti-hormonal therapy prior to study;
- 5-alpha-reductase inhibitors prior to study;
- significant cardiac arrhythmia current or in patient history;
- prior NYHA (New York Heart Association) class III-IV cardiac disease
or concurrent congestive heart failure;
- prior major thoracic and/or abdominal surgery from which the patient
has not yet recovered;
- known sensitivity to the study drug or components of the preparation;
- other concurrent investigational drugs within the past four weeks;
- other condition that, in the opinion of the investigators, would make
the patient unsuitable for this clinical trial.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objectives<br /><br>- to assess the safety of 275 MBq [68Ga]Sarabesin 3 (40 µg peptide) in patients<br /><br>with PC;<br /><br>= endpoints: adverse events (AE), with severity grading according to NCI<br /><br>CTCAE version 4.0; the causality of each AE to [68Ga]Sarabesin 3;<br /><br>= outcome measures: blood pressure, heart rate, haemoglobin, leucocytes,<br /><br>thrombocytes, CRP, sodium, potassium, calcium, phosphate, urea, creatinine,<br /><br>total protein, albumin, bilirubin, alkaline phosphatase, ALT, AST, gamma-GT,<br /><br>uric acid, glucose, and gastrin;<br /><br>- to determine the biodistribution of [68Ga]Sarabesin 3 in patients with PC;<br /><br>= endpoint: biodistribution of [68Ga]Sarabesin 3 will be assessed by PET;<br /><br>= outcome measures: qualitative and quantitative data per region of interest<br /><br>per patient within the available time points; </p><br>