Two TraCer PositROn EmiSSion Tomography ComBination for E... | NCT04085991

Studies
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

NCT04085991

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Status

Terminated

Last Update Posted

Apr 12, 2023Actual

Enrollment

11Actual

Phase

Phase 2

Conditions

Prostate Cancer
Prostate Adenocarcinoma
Prostatic Neoplasms
Metastatic Prostate Cancer
Metastatic Prostatic Adenocarcinoma
Metastatic Prostate Carcinoma in the Soft Tissue

Interventions

131I-PSMA-1095 Radioligand Therapy (RLT)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Drug no longer available

Expanded Access Info

Start Date

Jul 31, 2020Actual

Primary Completion Date

Jan 15, 2023Actual

Completion Date

Jan 15, 2023Actual

First Submitted Date

Sep 8, 2019

First Submission Date that Met QC Criteria

Sep 10, 2019

First Posted Date

Sep 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 12, 2023Actual

Description Module

Brief Summary

Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
131I-PSMA-1095 Radioligand Therapy (RLT)	Experimental	Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses	Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
131I-PSMA-1095 Radioligand Therapy (RLT)	Drug	Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.	131I-PSMA-1095 Radioligand Therapy (RLT)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum prostate specific antigen (PSA)	The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline.	3 months post last dose of RLT

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Frequency of adverse events in participants receiving therapy as per CTCAE v5.0	3 months post last dose of RLT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
Age 18 years or older
Documented metastatic adenocarcinoma of the prostate
Under active medical oncology care
ECOG performance status 0 - 3, inclusive
Able to understand and provide written informed consent
Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes
Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator
Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1
Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX
Life expectancy of at least 3 months as judged by the investigator

Exclusion Criteria:

Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter)
Unmanageable claustrophobia
Prior failure of PSMA RLT
Prior hemi-body irradiation
Impaired organ function as evidenced by any of the following laboratory values:
- Absolute neutrophil count < 1.5 x109/L
- Platelet count < 75 x109/L
- Hemoglobin < 85 g/L
- Albumin < 2.5 g/dL (25 g/L)
- Total bilirubin > 2 x ULN (unless in instances of Gilbert's disease)
- AST or ALT > 2.5 x ULN (or > 5.0 x ULN in the presence of liver metastases)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male only.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases