We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03253744
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : September 15, 2022
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 September 15, 2022
Actual Study Start Date  ICMJE July 5, 2018
Estimated Primary Completion Date June 20, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2021)
Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ]
Define the MTD of image-guided, focally dose escalated prostate SBRT in patients with a local recurrence of prostate cancer after prior radiotherapy.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2021)
  • Sensitivity and specifity of 18F-DCFPyl imaging as compared to biopsy in detecting locally recurrent prostate cancer [ Time Frame: 6 months after radiation ]
    Evaluate 18F-DCFPyL imaging as a method to detect locally recurrent prostate cancer after radiation. The sensitivity and specificity of DCF-PyL for detecting locally recurrent prostate cancer (at baseline) will be reported using biopsy as the gold standard.
  • Changes of quality of life scores during and after treatment [ Time Frame: 2 years after treatment ]
    Describe the effects of focally dose escalated prostate SBRT on patient reported outcomes (SHIM, AUA Symptom Index, EPIC-26) in patients previously treated with radiotherapy. The quality of life scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for patient-specific trajectory of quality of life scores. Changes of quality of life scores during and after treatment will be calculated from the estimated linear mixed effect model.
  • biochemical progression free survival [ Time Frame: 1 and 2 years after treamtnet ]
    Describe the rate of PSA control (bPFS, PSA < 2 ng/dL above post SBRT nadir) at 1 and 2 years after treatment with focally dose escalated SBRT for locally recurrent prostate cancer after irradiation: bPFS will be estimated by the Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model.
  • Assessment of Dose limiting toxicities [ Time Frame: 3 weeks after end of treatment ]
    Define the dose-limiting toxicities and toxicity profile of image-guided, focally dose escalated prostate SBRT in patients previously treated with radiotherapy: DLTs will be reported descriptively.
Original 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 ]
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.

Participantes will continue to have routine visits until two years after treatment is completed....

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 re-irradiation 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 6-6.5 mCi.
  • Radiation: Tumor Irradiation
    SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy
  • Radiation: Prostate + tumor 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 prostate cancer 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 prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate
    Interventions:
    • Drug: 18F-DCFPyL
    • Radiation: Prostate + tumor 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: November 19, 2021)
46
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2017)
52
Estimated Study Completion Date  ICMJE December 20, 2028
Estimated Primary Completion Date June 20, 2028   (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.
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
Contact: Deborah E Citrin, M.D. (240) 760-6206 citrind@mail.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
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Cancer Institute (NCI)
Original Study Sponsor  ICMJE Same as current
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 September 12, 2022

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