Cryotherapy, Prostate Cancer, Prostate Cancer Patients Treated by Radiotherapy, Prostate Cancer Patients Who Have Brachytherapy Seed Implant, Prostate Cancer Patients With Detectable PSA Following Prostatectomy, Prostate Cancer Recurrent
Conditions
Keywords
Prostate Cancer, Prostate, Biochemical Recurrence
Brief summary
The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
Interventions
DRUG64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA
Sponsors
Clarity Pharmaceuticals Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age. 2. Signed informed consent. 3. Life expectancy ≥ 6 months as determined by the Investigator. 4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. 5. Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2). 6. PSA level after definitive therapy: 1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or 2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition). 7. Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible. 8. An Eastern Cooperative Oncology performance status of 0-2.
Exclusion criteria
1. Participants who received investigational agent within 5 biological half-lives prior to Day 1. 2. Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1. 3. Participants with known predominant small cell or neuroendocrine PC. 4. Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation). 5. Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC. 6. Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant's involvement in the study. 7. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. 8. Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer | Up to 52 Weeks | Co-primary endpoints of participant-level CDR and region level PPV assessed independently for Day 1 and Day 2: * Participant-level CDR, defined as the proportion of TP participants scan out of all participants * Region-level PPV, defined as the proportion of TP regions out of all positive regions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the safety and tolerability of 64-CuSAR-bisPSMA | Up to 52 Weeks | Incidence and severity of TEAEs and SAEs following the administration of 64CuSARbisPSMA |
| To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT | Up to 52 Weeks | Participant-level PPV, defined as the proportion of participants with a TP scan out of all participants with a true or false positive scan. |
| To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT | Up to 52 Weeks | Participant-level DR, defined as the proportion of participants with a positive scan out of all participants. |
| To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline | Up to 52 Weeks | Detection Rate in participants with a negative or equivocal conventional imaging at baseline. |
| To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT | Up to 52 Weeks | Positive Predictive Value (participant- and region-level) assessed in subgroups based on the type of evidence and with/without histopathology. |
| To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings | Up to 52 Weeks | Inter-reader variability expressed with kappa statistics for the 64Cu-SAR-bisPSMA PET/CT interpretation by the three central readers. |
Countries
Australia, United States
Outcome results
None listed