RecruitingACTRN12615000608561

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.


Sponsor

Sir Charles Gairdner Hospital

Enrollment

40 participants

Start Date

May 28, 2015

Study Type

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

Sex: MalesMin Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of nuclear medicine scan called 68Ga-PSMA PET-CT to see how well it detects prostate cancer that has come back after initial treatment (surgery or radiation). Participants will have two scans over six months, and researchers will track how the scan results influence what treatment doctors decide to give. You may be eligible if: - You are male and 40 years of age or older - You have been diagnosed with prostate cancer confirmed by biopsy - Your PSA level has risen after surgery or radiation therapy, indicating possible cancer recurrence - Standard imaging (bone scan and CT) shows no cancer, or shows only a small number of spots (up to 4) You may NOT be eligible if: - Your prostate cancer has spread widely throughout the body - You have hormone-refractory (castration-resistant) prostate cancer Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12615000608561


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