Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Condition: Prostate Cancer; Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Intervention: 18F-DCFPyL; Tumor Irradiation; Prostate + tumor irradiation; Tumor Irradiation
Intervention description: Participants will receive 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.; Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.; Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.; External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Image Guidance; Dose Escalation; Radiotherapy; Re-irradiation; Quality of Life

Summary:

      Background:

      Prostate cancer is the second leading cause of cancer death in United States (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.

      Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an
      injection of
      2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic
      acid (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.

      Participants will continue to have routine visits until two years after treatment is
      completed....
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Patients must have histologically confirmed locally recurrent adenocarcinoma of the
             prostate after prior radiation (external beam radiation therapy (EBRT) or
             brachytherapy).

          -  Prostate-specific antigen (PSA) failure after definitive radiation as defined by the
             Phoenix criteria (PSA elevation at least 2 nanograms (ng) per deciliter (dL) above
             post-radiotherapy nadir)

          -  Age greater than or equal to 18 years.

          -  Eastern Cooperative Oncology Group (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
             2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedi
             oic acid (18F-DCFPyL) scan obtained (If PSA > 20 and 18F-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 (alanine aminotransferase (ALT), aspartate aminotransferase (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.