A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer

NCT03373006 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: DMI Axumin-001Protocol. No: 20171334Study No: 1176339
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Detection of Metastases

  Number of patients with detection of metastasis Secondary Outcome Measure Description: Number of patients with local uptake of Axumin

  One day

Study Arms (1)

Men with Gleason Score 7 prostate cancer

EXPERIMENTAL

Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.

Drug: Axumin PET/CT

Interventions

Axumin PET/CT DRUG

Synthetic amino acid uptake agent injection followed by imaging

Also known as: PET/CT scan

Men with Gleason Score 7 prostate cancer

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Men with Gleason 7 prostate cancer (3+4 or 4+3)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, 45 years of age or older.
• Diagnosis of prostate adenocarcinoma.
• Clinical stage T1a, T1b, T1c, T2a, T2b orT2c.
• Gleason score of 7 (3+4 or 4+3).
• PSA density less than 0.375.
• One, two, or three tumor suspicious regions identified on multiparametric MRI.
• Negative radiographic indication of extra-capsular extent.
• Karnofsky performance status of at least 70.
• Estimated survival of 5 years or greater, as determined by treating physician.
• Tolerance for anesthesia/sedation.
• Ability to give informed consent.

You may not qualify if:

• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• 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)
• History of other Primary non-skin malignancy within previous three years.
• Diabetes.
• Smoker.

Sponsors & Collaborators

• HALO Diagnostics: lead

Study Sites (1)

Desert Medical Imaging

Indian Wells, California, 92210, United States

Location

Related Publications (5)

• 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.

  PMID: 26053708 BACKGROUND

• 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.

  PMID: 27511856 BACKGROUND

• Jambor I, Kuisma A, Kahkonen E, Kemppainen J, Merisaari H, Eskola O, Teuho J, Perez IM, Pesola M, Aronen HJ, Bostrom PJ, Taimen P, Minn H. Prospective evaluation of 18F-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.

  PMID: 29147764 BACKGROUND

• 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.

  PMID: 29104741 BACKGROUND

• 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 18F-Fluciclovine PET/CT. J Nucl Med. 2017 Oct;58(10):1596-1602. doi: 10.2967/jnumed.116.188375. Epub 2017 Apr 6.

  PMID: 28385791 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

One limitation of this study was the mall sample size.

Results Point of Contact

• Title: Chief Research Officer
• Organization: HALO Diagnostics

bernadette@halodx.com

760-766-2047

Study Officials

• John F Feller, MD

  Medical Director, Radiation Safety Officer

  PRINCIPAL INVESTIGATOR

• Bernadette M Greenwood, MSc.

  Chief Research Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 14, 2017
• Study Start: February 27, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: May 25, 2022
• Results First Posted: June 4, 2020

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within one year of completing of patient #20.
• Access Criteria: Attendees at CME courses and researchers visiting Desert Medical Imaging may view data from our spreasdsheets and PACS. Case reports and anonymized data will be shared at scientific meetings.

Locations

US (1)