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Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

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ClinicalTrials.gov Identifier: NCT03253744
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE August 17, 2017
First Posted Date  ICMJE August 18, 2017
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE July 5, 2018
Estimated Primary Completion Date June 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ]
Define the MTD of imageguided, focally dose escalated prostate SBRT in patients with a local recurrence of prostate cancer after priorradiotherapy.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ]
Change History Complete list of historical versions of study NCT03253744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Assessment of Dose limiting toxicities [ Time Frame: 3 weeks after end of treatment ]
  • biochemical progression free survival [ Time Frame: 1 and 2 years after treamtnet ]
  • Changes of quality of life scores during and after treatment [ Time Frame: 2 years after treatment ]
  • Sensitivity and specifity of 18FDCFPyl imaging as compared tobiopsy in detecting locally recurrent prostate cancer [ Time Frame: 6 months after radiation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Official Title  ICMJE Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Brief Summary

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Prosatatic Neoplasm
Intervention  ICMJE
  • Drug: 18F-DCFPyL
    Subjects will receive 18F-DCFPyL 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 10 mCi.
  • Radiation: Tumor Irradiation
    SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy
  • Radiation: Prostate radiation + tumor boost irradiation
    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
Study Arms  ICMJE
  • Experimental: 1/Tumor Irradiation
    SBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy
    Interventions:
    • Drug: 18F-DCFPyL
    • Radiation: Tumor Irradiation
  • Experimental: 2/Prostate and Tumor Irradiation
    SBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate
    Interventions:
    • Drug: 18F-DCFPyL
    • Radiation: Prostate radiation + tumor boost irradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2017)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2021
Estimated Primary Completion Date June 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Theresa Cooley-Zgela, R.N. (301) 451-8905 theresa.cooleyzgela@nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03253744
Other Study ID Numbers  ICMJE 170153
17-C-0153
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 30, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP