Prostate Cancer Clinical Trial
Official title:
A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Laser Focal Therapy of Intermediate Risk Localized Prostate Cancer
Verified date | April 2022 |
Source | Desert Medical Imaging |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 30, 2020 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: 1. Male, 45 years of age or older. 2. Diagnosis of prostate adenocarcinoma. 3. Clinical stage T1a, T1b, T1c, T2a, T2b orT2c. 4. Gleason score of 7 (3+4 or 4+3). 5. PSA density less than 0.375. 6. One, two, or three tumor suspicious regions identified on multiparametric MRI. 7. Negative radiographic indication of extra-capsular extent. 8. Karnofsky performance status of at least 70. 9. Estimated survival of 5 years or greater, as determined by treating physician. 10. Tolerance for anesthesia/sedation. 11. Ability to give informed consent. Exclusion Criteria: 1. Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. 2. Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. ( (http://www.urospec.com/uro/Forms/ipss.pdf) 3. History of other Primary non-skin malignancy within previous three years. 4. Diabetes. 5. Smoker. |
Country | Name | City | State |
---|---|---|---|
United States | Desert Medical Imaging | Indian Wells | California |
Lead Sponsor | Collaborator |
---|---|
Desert Medical Imaging |
United States,
Jambor I, Kuisma A, Kähkönen E, Kemppainen J, Merisaari H, Eskola O, Teuho J, Perez IM, Pesola M, Aronen HJ, Boström PJ, Taimen P, Minn H. Prospective evaluation of (18)F-FACBC PET/CT and PET/MRI versus multiparametric MRI in intermediate- to high-risk prostate cancer patients (FLUCIPRO trial). Eur J Nucl Med Mol Imaging. 2018 Mar;45(3):355-364. doi: 10.1007/s00259-017-3875-1. Epub 2017 Nov 16. — View Citation
Miller MP, Kostakoglu L, Pryma D, Yu JQ, Chau A, Perlman E, Clarke B, Rosen D, Ward P. Reader Training for the Restaging of Biochemically Recurrent Prostate Cancer Using (18)F-Fluciclovine PET/CT. J Nucl Med. 2017 Oct;58(10):1596-1602. doi: 10.2967/jnumed.116.188375. Epub 2017 Apr 6. — View Citation
Nanni C, Schiavina R, Brunocilla E, Boschi S, Borghesi M, Zanoni L, Pettinato C, Martorana G, Fanti S. 18F-Fluciclovine PET/CT for the Detection of Prostate Cancer Relapse: A Comparison to 11C-Choline PET/CT. Clin Nucl Med. 2015 Aug;40(8):e386-91. doi: 10.1097/RLU.0000000000000849. — View Citation
Schreibmann E, Schuster DM, Rossi PJ, Shelton J, Cooper S, Jani AB. Image Guided Planning for Prostate Carcinomas With Incorporation of Anti-3-[18F]FACBC (Fluciclovine) Positron Emission Tomography: Workflow and Initial Findings From a Randomized Trial. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):206-13. doi: 10.1016/j.ijrobp.2016.04.023. Epub 2016 Apr 30. Erratum in: Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):231. — View Citation
Zarzour JG, Galgano S, McConathy J, Thomas JV, Rais-Bahrami S. Lymph node imaging in initial staging of prostate cancer: An overview and update. World J Radiol. 2017 Oct 28;9(10):389-399. doi: 10.4329/wjr.v9.i10.389. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of Metastases | Number of patients with detection of metastasis Secondary Outcome Measure Description: Number of patients with local uptake of Axumin |
One day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |