Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression. SECONDARY OBJECTIVES: I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests. II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c). III. To compare the positive predictive value (PPV) per-patient in patients with lesion validation (follow-up imaging or biopsy). OUTLINE: Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04928820
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date June 16, 2021
Completion date October 18, 2022

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Withdrawn NCT05034562 - Gallium-68 PSMA-11 PET in Participants With Prostate Cancer Phase 2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
Terminated NCT04134208 - An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer Phase 4
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