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Completed

NCT Number: NCT02680041

18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment

This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

City of Hope National Medical Center, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
  • Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
  • Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
  • Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
  • Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
  • Being considered for salvage therapy
  • Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
  • Previous brachytherapy treatment will have occurred at least 2 years in the past
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

  • Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
  • Androgen deprivation therapy (ADT) in the past 3 months
  • History of bilateral orchidectomy
  • Inability to tolerate 18F-fluciclovine PET/CT

Treatment and study plan

18F-fluciclovine PET CT

Drug

Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment

Other names: FACBC

Primary outcomes

  1. The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.

    Time frame: 2-22 days post PET CT

    The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT

Secondary outcomes

  1. The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment

    Time frame: 6 months

    The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up.

    Investigators were instructed to assess any clinically significant change from the revised management plan.

  2. The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population

    Time frame: 1 week

    The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT

  3. The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population

    Time frame: 1 week

    The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally

  4. The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy

    Time frame: 6 months

    Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI

  5. The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy

    Time frame: 6 months

    Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI

Sponsors and collaborators

Lead sponsor

Blue Earth Diagnostics

Industry

Collaborators

  • American College of Radiology
  • IND 2 Results LLC
  • Syne Qua Non Limited

Registry information

Official study title

The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment

Acronym: LOCATE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2016
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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