Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Can… (NCT04644822) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.
Canada100 participantsStarted 2020-12-21
Plain-language summary
This is a prospective, Phase 3 non-randomized, open label, multi-centre clinical trial to assess the safety and efficacy of \[18F\]PSMA-1007 Injection (investigational product or IP) in evaluating men with suspected persistent or recurrent disease (i.e., with biochemical failure), but with negative or equivocal conventional re-staging imaging (bone scan \[BS\] and computed tomography \[CT\] of abdomen and pelvis).
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Able to read and speak in English and provide informed consent
✓. Male, Age ≥ 18 years
✓. Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer or other local or focal ablative therapy of the prostate
✓. Not currently on systemic therapy (adjuvant or salvage) including androgen deprivation therapy
✓. Suspected progressive or persistent disease after primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:
✓. Following primary radical prostatectomy (with or without adjuvant or salvage radiotherapy to the prostate bed/pelvis), where BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment at \> 0.1 ng/mL
✓. Following primary radiotherapy (with either brachytherapy, external beam radiotherapy or combined brachytherapy and radiotherapy) for localized disease, where BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment greater than the nadir PSA + 2.0 ng/mL
✓. Following primary ablative therapy to the prostate given with radical intent such as prior HIFU (high intensity focused ultrasound) or cryotherapy or other ablative energy therapy with biochemical failure as defined by the Stuttgart Criteria (nadir PSA + 1.2 ng/mL within 3 months prior to enrollment )
Exclusion criteria
What they're measuring
1
Primary Endpoint:
Timeframe: 8 months
Trial details
NCT IDNCT04644822
SponsorCentre for Probe Development and Commercialization
. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
✕. Prior PSMA PET scan within 6 months of enrolment
✕. Use of any other investigational medication or devices within 30 days prior to Visit 1
✕. Known allergies or sensitivity to any component of the investigational product used in this study
✕. Received significant ionizing radiation exposure, as judged by the Investigator, including from diagnostic or therapeutic radiopharmaceuticals used in clinical trials or for routine medical examinations, in the last 12 months
✕. Undergoing ongoing occupational monitoring for radiation exposure
✕. Clinically active, unstable, serious, life-threatening medical condition or disease that is, in the opinion of the Investigator, inadequately treated and/or where study participation may compromise the clinical management of the subject, or any other reason that makes the subject unsuitable to participate in this study
✕. The participant has a history of alcohol or substance abuse