[68Ga]Ga-PSMA-11 PET/CT in the Assessment of High Risk and Recurrent Prostate Cancer

Launched by BRITISH COLUMBIA CANCER AGENCY · Jul 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new type of imaging called Gallium-68-PSMA-11 PET/CT scans to help detect prostate cancer that may have come back after treatment. Prostate cancer can return in the same area or spread to other parts of the body, and knowing where it has returned is important for deciding the best treatment. Current imaging techniques can sometimes miss cancer, especially when blood tests show low levels of a marker called PSA. The trial aims to see if this new scan can provide better information for men with high-risk or recurring prostate cancer.

To participate in this trial, men aged between 39 and 159 years old who have been diagnosed with prostate cancer may be eligible. Key requirements include having a certain level of risk for the cancer returning, confirmed cancer through a biopsy, and specific PSA levels depending on their treatment history. Participants will undergo the PET/CT scan and will be monitored for how well it helps identify their cancer status. It's important to know that some people may not be able to join due to medical conditions or if they cannot provide consent. This study could lead to improved care for men facing challenges with prostate cancer management.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group performance status of 2 or less.
• • Subjects with high risk prostate cancer (CAPRA score 6 or higher) being considered for curative-intent surgery or radiation therapy (including brachytherapy)
• • Subjects with biopsy confirmed prostate cancer being considered for curative-intent surgery or radiation therapy (including brachytherapy), who have unconfirmed suspicious findings on conventional medical imaging staging examinations.
• • Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy, with two consecutive PSA values \>0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL.
• • Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy and subsequently treated by salvage radiotherapy or pelvic node dissection, with two consecutive PSA values \>0.2 ng/ml. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL.
• • Subjects with biochemical recurrence of prostate cancer after initial curative therapy with radiation therapy (including brachytherapy), or non-standard local ablative therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.), with a PSA level \>2 ng/mL above the nadir after radiation therapy.
• • Subjects with advanced castration sensitive or castration resistant prostate cancer being considered for localized treatment (surgery, brachytherapy, radiotherapy) of recurrent or oligometastatic prostate cancer. Castration resistance is defined as a PSA level \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L).
• • Subjects with metastatic or castration resistant prostate cancer being evaluated for systemic therapy administered in therapeutic clinical trials. The PSA level must be \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L).
• Exclusion Criteria:
• • Medically unstable (e.g. acute illness, unstable vital signs)
• • Unable to lie supine for the duration of imaging
• • Unable to provide written consent
• • Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
• • Exclusion criteria for the use of furosemide Subjects can still participate in the research study and undergo the \[68Ga\]Ga-PSMA-11 scan if they are unable or unwilling to receive a furosemide injection.
• • Subjects with end stage renal disease.
• • Subjects with documented history of severe progressive chronic kidney disease (glomerular filtration rate less than 30 mL/min/1.73 m2).
• • Subjects with hypersensitivity to furosemide (Lasix).
• • While cross-reactivity between sulfonamide antibiotics and non-antibiotics has been disproven, subjects who have a history of sulfonamide antibiotics or sulfonylureas may be at a higher risk of allergic reaction to furosemide due to a higher general predisposition to allergic reactions. In those instances, the administration of furosemide is left at the discretion of the local site investigator after discussion with the study subject.
• • Subjects with severe hypokalemia, hyponatremia, hypovolemia, dehydration or hypotension.
• • Subjects with untreated bladder outlet obstruction or lower urinary tract symptoms, who have a history of obstructive episodes that required hospitalization, emergency department visits and/or bladder catheterization for relief of symptoms.