Clinical Trials /

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

NCT03253744

Description:

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....

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
  • Official Title: Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Clinical Trial IDs

  • ORG STUDY ID: 170153
  • SECONDARY ID: 17-C-0153
  • NCT ID: NCT03253744

Conditions

  • Prostate Cancer
  • Prosatatic Neoplasm

Interventions

DrugSynonymsArms
18F-DCFPyL1/Tumor 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....

Detailed Description

      Background:

      Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to
      the side effects of available treatments such as surgery and cryoablation. Re-irradiation
      with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer
      disease control with tolerable side effects. Using image guidance to allow highly conformal
      focal reirradiation may potentially increase the efficacy of re-irradiation.

      Objectives:

      -Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate
      radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence
      of prostate cancer after prior radiotherapy.

      Eligibility:

        -  Histological confirmation of recurrent prostate cancer after prior irradiation (external
           beam or brachytherapy)

        -  No evidence of distant metastases of prostate cancer

        -  No prior prostatectomy

        -  Subject is greater than or equal to18 years old

        -  ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to
           60%).

      Design:

      This is a Phase I trial of focal dose escalation with SBRT using image and pathologic
      guidance. Areas in the prostate shown to have tumor on biopsy or with advanced imaging
      studies will be treated with highly conformal SBRT over a period of two to three weeks.
      Treatment will be guided and gated by fiducials implanted in the prostate. Patients will be
      treated to escalating doses based on tolerability of the treatment. Quality of life and
      functional outcomes such as urine, bowel, and erectile function will be assessed with
      questionnaires. Up to 52 patients will be enrolled.
    

Trial Arms

NameTypeDescriptionInterventions
1/Tumor IrradiationExperimentalSBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy
  • 18F-DCFPyL
2/Prostate and Tumor IrradiationExperimentalSBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate
  • 18F-DCFPyL

Eligibility Criteria

        -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose
Time Frame:3 weeks post-treatment
Safety Issue:
Description:Define the MTD of imageguided, focally dose escalated prostate SBRT in patients with a local recurrence of prostate cancer after priorradiotherapy.

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Institute (NCI)

Trial Keywords

  • Image Guidance
  • Dose Escalation
  • Radiotherapy
  • Re-irradiation
  • Quality of Life

Last Updated

July 13, 2019