None listed
Conditions
Brief summary
The study aims to evaluate the sensitivity and specificity of Prostate Cancer Recurrence Sites by [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI) in Men with Biochemical Recurrence Following Definitive Therapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above with pathologically diagnosed prostate cancer and biochemical cancer recurrence. Study details: All participants will undergo [68Ga]Gallium-labelled Prostate Specific Membrane Antigen Binding Ligand Positron Emission Tomography/Magnetic Resonance Imaging (PSMA PET/MRI). If the scans demonstrate a lesion that is amenable to biopsy or surgery, the participants will undergo CT or ultrasound guided biopsy or surgical excision as part of their clinical management. Once a sample has been obtained, the 1st sample will be used for immunohistologic analysis and the 2nd sample will be sent for in vitro culture and further analyses. If archived tissues are available, genomic comparison of primary tumour specimens and metastatic/recurrent lesions will be performed. At 6, 12, 18 and 24 months after the 68Ga-HBED-CC PET/MRI, relevant prostate cancer data will be used for further analysis. The information will include blood tests (Prostate Specific Antigen, Full Blood Count, Urea and Electrolytes, Calcium, Liver Function Tests), imaging (CT, PET, MR or Bone scan) and clinical history. The novel imaging technology may identify evidence of metastatic disease, undetected by standard of care imaging. This information could alter the treatment plan potentially. The benefits of the translational aspects of the study are that a proof of principle precision medicine program may be established to attempt in vitro assessment of a patients’ tumour in a clinically relevant timeframe and to also develop novel cell lines for basic research. This may lead in the future to a larger trial utilizing such data to guide treatment decisions in men with advanced prostate cancer.
Interventions
[68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand (68Ga-PSMA)
Glu-NH-CO-NH-Lys-(Ahx)-[68Ga-N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'- diacetic acid]
The dosage form is intravenous (IV) solution. The strength is 150MBq. One infusion is needed for the scan. The infusion of the 68Ga-PSMA ligands takes about 45 mins. Then, 68Ga-PSMA PET/MR scan will be performed. The scan will take 1-2 hours..
There will be no additional scans for this study unless they
[68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand (68Ga-PSMA) Glu-NH-CO-NH-Lys-(Ahx)-[68Ga-N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'- diacetic acid] The dosage form is intravenous (IV) solution. The strength is 150MBq. One infusion is needed for the scan. The infusion of the 68Ga-PSMA ligands takes about 45 mins. Then, 68Ga-PSMA PET/MR scan will be performed. The scan will take 1-2 hours.. There will be no additional scans for this study unless they are clinically required. If the PSMA PET/MR scans demonstrate a lesion, the participants may undergo biopsy or surgical excision as part of clinical management. The decision of biopsy or surgical excision will be made between the participants, clinicians and members of Prostate Cancer Multi-Disciplinary Team Clinic. The specimens will be taken for pathology analysis for clinical management. They will also be cultured in laboratory for experimental uses.
Sponsors
Queensland University of Technology
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male patients with pathologically diagnosed prostate cancer 2. Biochemical Recurrence as defined: a. PSA > 0.2ng/ml on at least 2 occasions post radical prostatectomy b. PSA 2.0ng/ml above nadir 2 years post radiotherapy 3. History of primary treatment for prostate cancer no sooner than 3 months post-surgery and 2 years post radiotherapy 4. No known problems with peripheral intravenous or central line access 5. Able to provide informed signed consent
Exclusion criteria
1. Age under 18 years 2. Administered a radioisotope within 5 physical half-lives prior to study enrolment 3. Unable to lie flat during or unable to tolerate PET/MRI 4. Prior history of any other malignancy within last 2 years 5. Contraindication to PET scan or [68Ga]Gallium-labelled PSMA ligand 6. Claustrophobia not manageable by oral sedatives i.e. Temazepam 7. Renal impairment or haemodialysis. 8. Contraindication to biopsy of identified lesion 9. Contraindication to MRI such as implantable medical devices 10. Body weight above 150kg or axial diameter larger than 60cm
Outcome results
None listed