Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit

NCT03183544 | Completed Phase 1

• 1 other identifier: 2017/30MAI/305
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the most common cancer in men. Early detection of primary diseases and recurrence is crucial for patient counseling and management. Conventional imaging modalities (CT-MRI) are limited to detect recurrence. Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and in patients with suspicious recurrent disease. Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier, ANMI, has developed a kit formulation of PSMA-11 which will be test in this clinical trial.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma concentration

  Measures based on blood tests

  at day 0

• Maximum Urine concentration

  Based on urine samples

  Up to 6 months

Secondary Outcomes (2)

• Time dependant changes of the injected activity per organ

  at day 0

• Incidence of treatment emergent adverse events

  Up to 6 months

Study Arms (1)

Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit

EXPERIMENTAL

Single injection for diagnostic use only

Combination Product: Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit

Interventions

Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit COMBINATION_PRODUCT

The patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment.

Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: This protocol concerns only patients with prostatic cancer and male healthy volunteers.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all individuals
• Male gender
• Normal renal function (MDRD glomerular filtration rate \>60/ml/min/1.73m2)
• Normal liver function (bilirubin, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and gamma glutamyltransferase \[GGT\] \<2x upper limit of normal \[ULN\]
• Normal bone marrow function (hemoglobin \[Hb\]\>12g/dl, white blood cells \[WBC\]\>4500/µl, platelets\>140,000/µl)
• Informed consent For patients with limited recurrent prostate cancer
• ≥18 years of age
• Radical therapy by surgery or radiotherapy
• Ability to undergo a one-day experimental study and the appropriate follow-up For healthy volunteers
• years of age
• No known prostate disease according to medical history, current symptoms and digital rectal examination
• PSA level \<3ng/ml
• Ability to undergo a two-day experimental study within a time interval of 7-15 days and the appropriate follow-up.

You may not qualify if:

• For all individuals
• Urinary incontinence
• Chronic renal disease (except nephroangiosclerosis or early diabetic nephropathy) even if renal function is normal
• Concomitant malignant disease or diagnosis of cancer within five years prior to enrollment (except basal cell carcinoma)
• History of salivary gland disease (except recovered childhood mumps)
• History of surgery or radiotherapy of the salivary gland or neck
• Medical or psychiatric condition that would preclude the conduct of the study to its end
• Pregnant partner

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• François Jamar, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 5 patients with limited recurrent prostate cancer and 3 healthy volunteers will be enrolled in this clinical trial

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 12, 2017
• Study Start: January 24, 2019
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)