FACBC for Recurrent Prostate Cancer

• ClinicalTrials.gov Identifier: NCT01808222
• Recruitment Status: Completed
• First Posted: March 11, 2013
• Results First Posted: January 7, 2019
• Last Update Posted: January 7, 2019
• Sponsor: David M. Schuster, MD
• Information provided by (Responsible Party): David M. Schuster, MD, Emory University

Study Description

Brief Summary:

The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.

Condition or disease	Intervention/treatment	Phase
Recurrent Prostate Cancer	Drug: FACBC	Phase 2

Detailed Description:

Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy. Significant advances have been made which have improved the cancer control outcomes and treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent (returning) disease usually displays rising Prostate-Specific Antigen (PSA) (a blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (i.e. recurrence in the prostate bed) from recurrence outside of the prostate bed (extra-prostatic recurrence). Imaging plays a central role in the detection of recurrent prostate carcinoma in the prostate bed and in the differentiation of prostatic from extraprostatic recurrence. There are newer methods of imaging such as magnetic resonance imaging (MRI) and positron emission tomography (PET) with molecular radiotracers that are currently under study for the imaging of post-therapy recurrence.

One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with other methods in the restaging of patients with suspected recurrent prostate carcinoma. FACBC has been tested in over 140 subjects in other studies in the Emory system including 128 subjects with prostate cancer.

The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA.

All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate. Biopsy of the suspected recurrence sites will be scheduled at the subjects' convenience as soon as possible after the scans.

Tissue obtained from the biopsy will undergo standard analysis to determine if prostate carcinoma cells are present. The secondary aim is to use left-over biopsy material to determine if there are genotypic differences between prostate carcinoma recurrence confined to the prostate bed and extraprostatic recurrence

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Transmolecular Imaging of Recurrent Prostate Carcinoma With Exploration of Genomic Markers Differences Between Local and Distant Recurrence
• Study Start Date: November 2013
• Actual Primary Completion Date: September 13, 2017
• Actual Study Completion Date: September 13, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: FACBC; Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT detection of cancer recurrence.	Drug: FACBC; Participants will receive a bolus of anti-[18F]FACBC injected IV over 1-2 minutes. The dosage will be approximately 10.0 millicuries (mCi) (3.70 x 108 becquerel (Bq)).; Other Name: anti-[18F]FACBC

Outcome Measures

Primary Outcome Measures :

1. The Presence of Cancer Tissue Inside of the Prostate Bed [ Time Frame: Up to 43 months ]

   Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:

   1. = definitely benign
   2. = probably benign
   3. = equivocal
   4. = probably malignant
   5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease.
2. The Presence of Cancer Tissue Outside of the Prostate Bed [ Time Frame: Up to 43 months ]

   Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:

   1. = definitely benign
   2. = probably benign
   3. = equivocal
   4. = probably malignant
   5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients must be 18 years of age or older.
2. Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive non-prostatectomy therapy for localized disease.
3. In the case of cryotherapy, external beam radiation, or High-Intensity Focused Ultrasound (HiFU) the procedure will have occurred at least one year in the past. In the case of brachytherapy, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
4. Patient will have suspicion of recurrent prostate carcinoma as defined by: the Radiation Therapy Oncology Group (RTOG) - American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix criteria of nadir PSA +2, and absolute PSA ≥ 4.0 ng/ml.with any doubling time (DT) or with PSA 2.0-3.99 ng/ml with DT ≤10 months
5. Ability to lie still for PET scanning
6. Patients must be able to provide written informed consent.

Exclusion Criteria:

1. Age less than 18.
2. Greater than T3 disease in past and/or treated with prostatectomy.
3. Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy..
4. Does not meet above criteria of suspicious PSA elevation
5. Inability to lie still for PET scanning
6. Cannot provide written informed consent.
7. Bone scan findings characteristic for metastatic prostate carcinoma

8. Less than 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation).

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Contacts and Locations

Locations

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

David M. Schuster, MD

Investigators

• Principal Investigator: David M Schuster, MD; Emory University

  Study Documents (Full-Text)

Documents provided by David M. Schuster, MD, Emory University:

Study Protocol and Statistical Analysis Plan  [PDF] December 4, 2014

More Information

Publications of Results:

Akin-Akintayo O, Tade F, Mittal P, Moreno C, Nieh PT, Rossi P, Patil D, Halkar R, Fei B, Master V, Jani AB, Kitajima H, Osunkoya AO, Ormenisan-Gherasim C, Goodman MM, Schuster DM. Prospective evaluation of fluciclovine ((18)F) PET-CT and MRI in detection of recurrent prostate cancer in non-prostatectomy patients. Eur J Radiol. 2018 May;102:1-8. doi: 10.1016/j.ejrad.2018.02.006. Epub 2018 Feb 24.

• Responsible Party: David M. Schuster, MD, MD, Emory University
• ClinicalTrials.gov Identifier: NCT01808222
• Other Study ID Numbers: IRB00061518; FACBC2 ( Other Identifier: Other )
• First Posted: March 11, 2013
• Results First Posted: January 7, 2019
• Last Update Posted: January 7, 2019
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:

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