Clinical trial NCT04839367: Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)
Official title: Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Neoplasms
Lead sponsor: Clarity Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.

Detailed description: This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent;
* ≥18 years of age;
* Life expectancy \>3 months;
* Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
* Have ≥1 of the following intermediate- to high-risk features:

  1. PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
  2. International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
  3. Clinical stage greater than or equal to T2b;
* Participants must have adequate renal function;
* Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;
* A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.

Exclusion Criteria:

* Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
* Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
* Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
* Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
* Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.

Primary outcomes:
measure: Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5
timeFrame: 11 weeks
measure: Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology
timeFrame: 11 weeks
Secondary outcomes:
measure: Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Murdoch
country: Australia
facility: GenesisCare CTA, SJOG Medical Clinic
state: Western Australia
Study officials:
References: