FACBC for Recurrent Prostate Cancer

NCT01808222 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB00061518FACBC2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• The Presence of Cancer Tissue Inside of the Prostate Bed

  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.

  Up to 43 months

• The Presence of Cancer Tissue Outside of the Prostate Bed

  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.

  Up to 43 months

Study Arms (1)

FACBC

EXPERIMENTAL

Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT detection of cancer recurrence.

Drug: FACBC

Interventions

FACBC DRUG

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)).

Also known as: anti-[18F]FACBC

FACBC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years of age or older.
• 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.
• 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."
• 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
• Ability to lie still for PET scanning
• Patients must be able to provide written informed consent.

You may not qualify if:

• Age less than 18.
• Greater than T3 disease in past and/or treated with prostatectomy.
• Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy..
• Does not meet above criteria of suspicious PSA elevation
• Inability to lie still for PET scanning
• Cannot provide written informed consent.
• Bone scan findings characteristic for metastatic prostate carcinoma
• Less than 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation).

Sponsors & Collaborators

• David M. Schuster, MD: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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 (18F) 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.

  PMID: 29685521 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David Schuster MD
• Organization: Emory University

dschust@emory.edu

404-712-4859

Study Officials

• David M Schuster, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 11, 2013
• Study Start: November 1, 2013
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: January 7, 2019
• Results First Posted: January 7, 2019

Record last verified: 2018-12

Locations

US (1)