Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04134208
Other study ID # 2019-0030
Secondary ID NCI-2019-0604720
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 19, 2019
Est. completion date June 28, 2022

Study information

Verified date July 2022
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.


Description:

PRIMARY OBJECTIVE: I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation therapy (ADT) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (PSA) response. SECONDARY OBJECTIVES: I. To correlate pelvic 18F-fluciclovine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18F-fluciclovine PET imaging sensitivity and specificity for pelvic lymph node cancer involvement. II. To evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival (defined by Prostate Cancer Working Group 2 [PCWG2] criteria). III. To determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. IV. To evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with target to blood pool ratio (TBR) following ADT plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and PSA response. OUTLINE: Within 4 weeks before starting standard systemic therapy (SST), patients receive fluciclovine F18 intravenously (IV) then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 28, 2022
Est. primary completion date June 28, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically or cytologically proven prostate carcinoma - Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI) - Castration naive disease, no prior systemic therapy for prostate cancer - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - Ability to understand and willingness to sign informed consent Exclusion Criteria: - Known brain metastasis - Small cell carcinoma of the prostate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Computed Tomography
Undergo PET-CT scan
Drug:
Fluciclovine F18
Given IV
Procedure:
Positron Emission Tomography
Undergo PET-CT scan

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metabolic response by fluciclovine F18 (18F-fluciclovine) positron emission tomography (PET) with standardized uptake values (SUV) Will evaluate metabolic response by 18F-fluciclovine PET qualitatively and semi-quantitatively with SUV and correlate the findings with size changes as defined by conventional imaging prostate specific antigen (PSA) response. The percentage of change in the 18F-fluciclovine maximum standardized uptake value (SUVmax) after therapy will be calculated as follows ([pretreatment corrected SUVmax - posttreatment corrected SUVmax]/pretreatment corrected SUVmax) x 100. Similar calculations will be performed for mean SUV, metabolic tumor volume, and total volume activity. Up to 2 years
Secondary 18F-fluciclovine PET imaging response Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. Up to 2 years
Secondary Sites of progressive disease development Will determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. Up to 2 years
Secondary Metabolic response by 18F-fluciclovine PET with target to blood pool ratio (TBR) Will evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with TBR and correlate the findings with size changes as defined by conventional imaging and PSA response. Up to 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04716725 - 68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer Phase 2
Withdrawn NCT05034562 - Gallium-68 PSMA-11 PET in Participants With Prostate Cancer Phase 2
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Recruiting NCT02935023 - Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer Phase 2
Terminated NCT02491411 - Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel N/A
Completed NCT01881867 - CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT04423211 - Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging Phase 3
Active, not recruiting NCT02807805 - Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer Phase 2
Completed NCT03707184 - Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone Phase 2
Recruiting NCT04071236 - Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy Phase 1/Phase 2
Active, not recruiting NCT02522715 - Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Phase 1/Phase 2
Withdrawn NCT04585932 - Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Active, not recruiting NCT05241860 - Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) Phase 2
Terminated NCT02985021 - Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies Phase 2
Not yet recruiting NCT05487846 - Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation N/A
Recruiting NCT04159896 - ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Completed NCT05547386 - 68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer Phase 3
Active, not recruiting NCT03517969 - M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2