search
Back to results

Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer

Primary Purpose

Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Gallium Ga 68 Gozetotide
Positron Emission Tomography
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Castration-Resistant Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven prostate cancer
  • Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml;
  • Castration resistant disease with confirmed testosterone level =< 50 ng/ml under prior first-line androgen deprivation therapy (ADT)
  • New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide
  • Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist
  • Stated willingness to comply with continuation of ARSI treatment for the duration of the study
  • Provision of signed and dated informed consent form

Exclusion Criteria:

  • Inability to provide written informed consent
  • Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
  • Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
  • A baseline superscan pattern on bone scan
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (68GA-PSMA-11 PET/CT)

Arm Description

Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

Outcomes

Primary Outcome Measures

Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI)
Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.

Secondary Outcome Measures

Prostate specific antigen (PSA) kinetics under ARSI
Comparison of 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes over time to PSA kinetics under ARSI. Will use mixed effects regression models to correlate the PSMA and PSA time trends. These models will include the effect of time and the PSMA by time interaction effect.
Biochemical progression free survival (bPFS)
Correlation between 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes and time of bPFS under ARSI. Will utilize Cox-proportional hazards regression models. PSMA results will be treated as a time dependent covariate in these models.
Changes in lesion size on cross sectional imaging under ARSI
Correlation between SUVmax from 68Ga-PSMA-11 PET and lesion size on cross sectional imaging under ARSI.
Changes in staging (PSMA miTNM PROMISE criteria) under ARSI
Will utilize mixed effects regression models to evaluate the change in staging over time.
Incidence of adverse events
Assessed by Common Terminology Criteria for Adverse Events 4.03.

Full Information

First Posted
February 19, 2020
Last Updated
September 19, 2022
Sponsor
Jonsson Comprehensive Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04279561
Brief Title
Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer
Official Title
Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI). SECONDARY OBJECTIVES: I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics. II. To correlate PSMA imaging changes with progression free survival. III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation [PROMISE] criteria) under ARSI. OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV). After 50-100 minutes, patients undergo positron emission tomography (PET)/computed tomography (CT) over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (68GA-PSMA-11 PET/CT)
Arm Type
Experimental
Arm Description
Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo 68Ga-PSMA-11 PET/CT
Intervention Type
Drug
Intervention Name(s)
Gallium Ga 68 Gozetotide
Other Intervention Name(s)
(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo 68Ga-PSMA-11 PET/CT
Primary Outcome Measure Information:
Title
Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI)
Description
Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.
Time Frame
Baseline, assessed up to 1 year
Secondary Outcome Measure Information:
Title
Prostate specific antigen (PSA) kinetics under ARSI
Description
Comparison of 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes over time to PSA kinetics under ARSI. Will use mixed effects regression models to correlate the PSMA and PSA time trends. These models will include the effect of time and the PSMA by time interaction effect.
Time Frame
Baseline, assessed up to 1 year
Title
Biochemical progression free survival (bPFS)
Description
Correlation between 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes and time of bPFS under ARSI. Will utilize Cox-proportional hazards regression models. PSMA results will be treated as a time dependent covariate in these models.
Time Frame
Up to 1 year
Title
Changes in lesion size on cross sectional imaging under ARSI
Description
Correlation between SUVmax from 68Ga-PSMA-11 PET and lesion size on cross sectional imaging under ARSI.
Time Frame
Up to 1 year
Title
Changes in staging (PSMA miTNM PROMISE criteria) under ARSI
Description
Will utilize mixed effects regression models to evaluate the change in staging over time.
Time Frame
Up to 1 year
Title
Incidence of adverse events
Description
Assessed by Common Terminology Criteria for Adverse Events 4.03.
Time Frame
Up to 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven prostate cancer Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml; Castration resistant disease with confirmed testosterone level =< 50 ng/ml under prior first-line androgen deprivation therapy (ADT) New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist Stated willingness to comply with continuation of ARSI treatment for the duration of the study Provision of signed and dated informed consent form Exclusion Criteria: Inability to provide written informed consent Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes) Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy A baseline superscan pattern on bone scan Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremie Calais
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer

We'll reach out to this number within 24 hrs