RECRUITING

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Conditions

Prostatic Neoplasms, Castration-Resistant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Official Title

A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer

Quick Facts

Study Start:2021-08-11

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04868604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Signed informed consent; * ≥18 years of age; * Eastern Cooperative Oncology Group performance status of 0 to 2; * Life expectancy \>6 months; * Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa); * Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value \[SUV\] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan; * Castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L); * Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria: 1. Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL; 2. Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions; 3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan. * ≥1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study; * Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.); * Participants must have adequate organ function: * Bone marrow reserve: * White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR * Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL); * Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL); * Hemoglobin ≥9 g/dL (5.59 mmol/L); * Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted; * Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases; * Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min * For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator; * For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.	* Major surgery within 12 weeks prior to enrollment into the study; * Brain metastasis; * Histologic diagnosis of small cell or neuroendocrine prostate cancer; * Prior history of leukemia or Myelodysplastic Syndrome; * Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study; * Unmanageable urinary tract obstruction; * Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET/CT scan as determined at screening; * Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor; * Previous treatment with any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is discontinued prior to enrolment, 14 days must elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids; * Previous treatment with any investigational agents within 4 weeks prior enrollment into the study; * Known hypersensitivity to the components of the investigational products or its analogues; * Transfusion for the sole purpose of making a participant eligible for study inclusion; * Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression; * Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation; * 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 condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care); * Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study.

Inclusion Criteria

Exclusion Criteria

* Signed informed consent;
* ≥18 years of age;
* Eastern Cooperative Oncology Group performance status of 0 to 2;
* Life expectancy \>6 months;
* Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa);
* Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value \[SUV\] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan;
* Castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L);
* Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria:
1. Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL;
2. Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions;
3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
* ≥1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study;
* Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.);
* Participants must have adequate organ function:
* Bone marrow reserve:
* White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR
* Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL);
* Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL);
* Hemoglobin ≥9 g/dL (5.59 mmol/L);
* Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
* Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases;
* Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min
* For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;
* For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

* Major surgery within 12 weeks prior to enrollment into the study;
* Brain metastasis;
* Histologic diagnosis of small cell or neuroendocrine prostate cancer;
* Prior history of leukemia or Myelodysplastic Syndrome;
* Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
* Unmanageable urinary tract obstruction;
* Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET/CT scan as determined at screening;
* Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor;
* Previous treatment with any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is discontinued prior to enrolment, 14 days must elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids;
* Previous treatment with any investigational agents within 4 weeks prior enrollment into the study;
* Known hypersensitivity to the components of the investigational products or its analogues;
* Transfusion for the sole purpose of making a participant eligible for study inclusion;
* Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;
* Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;
* 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 condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care);
* Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study.

Contacts and Locations

Study Contact

Clarity Pharmaceuticals

CONTACT

+61 (0) 2 9209 4037

clinicaltrials@claritypharmaceuticals.com

Principal Investigator

Clarity Pharmaceuticals

STUDY_DIRECTOR

Clarity Pharmaceuticals

Study Locations (Sites)

Stanford Cancer Institute

Stanford, California, 94305

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Washington University School of Medicine at Barnes-Jewish Hospital

Saint Louis, Missouri, 63110

United States

GU Research Network

Omaha, Nebraska, 68130

United States

Weill Cornell Medicine at New York-Presbyterian

New York, New York, 10021

United States

Collaborators and Investigators

Sponsor: Clarity Pharmaceuticals Ltd

Clarity Pharmaceuticals, STUDY_DIRECTOR, Clarity Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-11

Study Completion Date2026-09

Study Record Updates

Study Start Date2021-08-11

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Prostatic Neoplasms, Castration-Resistant