Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Condition: Prostate Cancer, Prosatatic Neoplasm


  • Drug: 18F-DCFPyL
  • Radiation: Tumor Irradiation
  • Radiation: Prostate radiation + tumor boost irradiation

Purpose: Background: Prostate cancer is the second leading cause of cancer death in U.S. men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT). Objective: To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation. Eligibility: Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease Design: Participants will be screened with blood tests, physical exam, and medical history. They may also have: Magnetic resonance imaging (MRI) scan of the prostate.. PET/CT scan. Participants will get an injection of 18F-DCFPyL for the PET scan. They will lie very still on their back on the scanner table. Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation. About 2 weeks later, participants will have a radiation treatment planning CT scan. Participants will answer questions about their urine function, bowel function, erectile function, and mood. Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks. Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires. Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated….

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03253744

Sponsor: National Cancer Institute (NCI)

Primary Outcome Measures:

  • Measure: Maximum tolerated dose
  • Time Frame: 3 weeks post-treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Assessment of Dose limiting toxicities
  • Time Frame: 3 weeks after end of treatment
  • Safety Issue:
  • Measure: biochemical progression free survival
  • Time Frame: 1 and 2 years after treamtnet
  • Safety Issue:
  • Measure: Changes of quality of life scores during and after treatment
  • Time Frame: 2 years after treatment
  • Safety Issue:
  • Measure: Sensitivity and specifity of 18FDCFPyl imaging as compared tobiopsy in detecting locally recurrent prostate cancer
  • Time Frame: 6 months after radiation
  • Safety Issue:

Estimated Enrollment: 52

Study Start Date: July 5, 2018

Phase: Phase 1


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (EBRT or brachytherapy).
  • PSA failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 ng/dL above post-radiotherapy nadir)
  • Age greater than or equal to 18 years.
  • ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
  • Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who are receiving any other investigational agents.
  • PSA greater than or equal to 20 ng/dL if no prior DCFPyL scan obtained (If PSA > 20 and DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study)
  • Biochemical recurrence within one year of completion of radiotherapy
  • Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
  • Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
  • Inflammatory bowel disease
  • Active Lupus or Active scleroderma
  • Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion)
  • Prior prostatectomy
  • Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
  • Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
  • Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures
  • Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
  • Serum creatinine > 2 times the upper limit of normal
  • Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert s syndrome, a total bilirubin > 3.0.
  • Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal
  • Patients with positive Human Immunodeficiency Virus (HIV) status and currently requiring treatment with agents known to sensitize to irradiation, such as protease inhibitors, will be excluded


  • Theresa Cooley-Zgela, R.N.
  • (301) 451-8905


  • National Institutes of Health Clinical Center
  • Bethesda Maryland 20892 United States

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