68Ga-PSMA PET-CT in biochemical relapse following primary treatment of Prostate Carcinoma (PCa)
Clinical utility of Gallium 68 Prostate Specific Membrane Antigen (68Ga-PSMA) Positron Emission Tomography (PET) imaging in patients with initial biochemical relapse following definitive surgery or radiotherapy for prostate carcinoma (PCa), to determine the sensitivity of 68Ga-PSMA imaging in the detection of PCa and using intention to treat analysis to assess change in management.
Sir Charles Gairdner Hospital
40 participants
May 28, 2015
Interventional
Conditions
Summary
This study is investigating the sensitivity of Gallium 68 -Prostate Specific Membrane Antigen (68Ga-PSMA) Positron Emission Tomography (PET) imaging in the detection of recurrent prostate carcinoma. Intention to treat analysis will be used to assess the impact of the 68Ga-PSMA PET on clinical management. Who is it for? You may be eligable for this study if you are over 40 years of age and have initial biochemical relapse, based on serum prostate specific antigen (PSA), following surgery or radiotherapy for prostate carcinoma, and have either no evidence of disease, or have oligometastatic disease (up to a maximum of four lesions) on current staging imaging. Study details: All participants in this study will undergo 2 68Ga-PSMA PET scans, 1 within a month of joining the trial and 1 six months later. These scans would not normally be part of routine care. The scans involve injection of a radioactive tracer. Participants will be followed up 3 months after the final scan to determine what treatment has been performed. This information will be used to evaluate the usefulness of the 68Ga-PSMA PET scans in detecting recurrent prostate carcinoma and determining how the scans affect clinical management. There are no additional appointments to attend outside your normal treatment visits except for the 2 PET scan visits, which should take approximately 2-3 hours. All followup data will be collected from your medical notes when you attend your routine treatment appointments.
Eligibility
Inclusion Criteria6
- Histologically confirmed prostate carcinoma
- Initial biochemical relapse following definitive treatment (Surgery or XRT) for prostate carcinoma or biochemical relapse at least 6 months following previous systemic (hormonal) treatment. (Biochemical relapse defined as PSA>0.2ng/mL at >6 weeks post radical prostatectomy or a PSA level 2 ng/mL above the previous PSA nadir measured >3 months after external beam radiotherapy-EBRT).
- Standard staging imaging, bone scan and abdominal CT, performed within 4 weeks of referral, showing no or oligometastatic disease. (Oligometastatic disease includes up to a maximum of four lesions.)
- No other active neoplastic disease
- Able to undergo study procedures / treatment
- Able to provide informed consent
Exclusion Criteria2
- Disseminated prostate carcinoma
- Hormone refractory prostate carcinoma
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Interventions
Gallium 68 Prostate Specific Membrane Antigen Positron emission tomography (68Ga-PSMA PET) scans will be performed on study participants within 4 weeks of study recruitment. A follow up scan will be performed 6 months later. 68Ga PSMA PET imaging requires tracer administration through a peripheral intravenous cannula. 2MBq/kg of 68Ga-PSMA will be administered intravenously as a slow push. At approximately1 hour following tracer administration, PET emission and transmission data will be acquired from mid-thigh to skull vertex. Duration of the imaging scan is approximately 40 minutes.
Locations(1)
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ACTRN12615000608561