None listed
Conditions
Brief summary
The purpose of this study is to determine the effect of androgen deprivation therapy, a treatment commonly prescribed in prostate cancer patients, on the effectiveness of medical imaging techniques. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic prostate cancer. Study details: Participants are required to undergo 2 PSMA Scans, the 1st within 28days prior to starting treatment with the medication enzalutamide and the 2nd 14 days after starting enzalutamide. Participants will be required to undergo a physical exam with the Dr which will include a blood test to assess kidney function. The outcome of this study will have important implications for the diagnostic and therapeutic management of metastatic prostate cancer.
Interventions
68Ga-PSMA-PET/CT scan will be administered in a registered nuclear medicine department by a nuclear med physician. This scan is considered standard of care for patients and this trial requires 1 additional scan under the same conditions as a standard PSMA scan. All participants are will be undergoing enzalutamide as standard of care. PSMA scans takes approx. 2-3 hours to complete. The second scan will be 7 weeks from the baseline scan. The Enzalitamide dosing is based on clinician choice (medic
68Ga-PSMA-PET/CT scan will be administered in a registered nuclear medicine department by a nuclear med physician. This scan is considered standard of care for patients and this trial requires 1 additional scan under the same conditions as a standard PSMA scan. All participants are will be undergoing enzalutamide as standard of care. PSMA scans takes approx. 2-3 hours to complete. The second scan will be 7 weeks from the baseline scan. The Enzalitamide dosing is based on clinician choice (medical oncologist) Enzalutimdie will commence at Week 5 (4 weeks post the 1st PSMA Scan) will continue throughout study as prescribed by treating Med Onc.
Sponsors
GenesisCare
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
• Male, aged 18 years or over • Metastatic prostate cancer with demonstrated resistance to standard ADT • Eastern Cooperative Oncology Group (ECOG) score 0 or 1 or 2 • Willing and able to comply with all study requirements, including all imaging and pre- and post-study assessments • estimated glomerular filtration rate (eGFR) greater than or equal to 40 mL/min/1.73 m^2
Exclusion criteria
• Prostate cancer with significant neuroendocrine or sarcomatoid component • Chemotherapy within previous two months • External beam radiotherapy within previous two months • Current use of abiraterone, or use within previous two months • Known intolerance or hypersensitivity to enzalutamide, or patient in whom enzalutamide is contraindicated • Known hypersensitivity to CT imaging intravenous contrast agent • Known hypersensitivity to any isotope of Ga in any chemical form, or any of the PSMA-targeting ligands • Significant urinary incontinence • Any mental condition or cognitive impairment that may render the patient unable to adequately understand the requirements, nature and possible consequences of the study
Outcome results
None listed