PSMA-PET/CT Registry
Megadott ok: Not due to a safety concern; terminated early due to changing clinical trial landscape at centre
Key facts
- Where
- Calgary, KanadaSee the site
Where in Kanada
- Tom Baker Cancer Centre/Arthur J E Child Comprehensive Cancer CentreCalgary, KanadaNo longer taking part
Trial details
- Who runs it
- AHS Cancer Control Alberta
- Trial code
- NCT05709535
- Record updated
- 2024. december 18.
- Original description
This is a prospective registry study to evaluate the diagnostic utility of [18F]-PSMA-1007 (PSMA-PET/CT) to stage patients with high-risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before onset of new therapy.Read full original descriptionShow less
PSMAN: POET PSMA-PET/CT Registry for High-Risk, Biochemically Relapsed, and Advanced Prostate Cancer
This is a prospective registry study to evaluate the diagnostic utility of [18F]-PSMA-1007 (PSMA-PET/CT) to stage patients with high-risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before onset of new therapy.
Inclusion: Study participant has provided informed consent prior to initiation of any study specific activities/procedures; Age greater than or equal to 18 years; Subjects with histological diagnosis of prostate cancer; Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 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 OR; 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 OR; 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 OR; 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) OR; 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) OR; Subjects with high-risk prostate cancer, defined as T3a, Gleason ≥8, or PSA ≥20, and "very high risk" as T3b or T4 disease; Patients of childbearing potential must adhere to the contraception requirement from screening throughout the study period up to 90 days after the last dose of study intervention.
Exclusion: History of allergic reaction to [18F]-PSMA-1007; 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); Lack of IV access.