Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

NCT04839367 | Completed Phase 1

• 1 other identifier: CLP03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5

  Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.

  11 weeks

• Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology

  Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology.

  11 weeks

Secondary Outcomes (1)

• Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq).

  11 weeks

Study Arms (3)

Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA

EXPERIMENTAL

Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA.

Drug: 64Cu-SAR-bisPSMA

Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA

EXPERIMENTAL

Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA.

Drug: 64Cu-SAR-bisPSMA

Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA

EXPERIMENTAL

Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA.

Drug: 64Cu-SAR-bisPSMA

Interventions

64Cu-SAR-bisPSMA DRUG

64Cu-SAR-bisPSMA

Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA; Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA; Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
• International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clarity Pharmaceuticals Ltd: lead

Study Sites (3)

Nepean Hospital

Kingswood, New South Wales, 2751, Australia

Location

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

GenesisCare CTA, SJOG Medical Clinic

Murdoch, Western Australia, 6150, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: July 13, 2021
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)