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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 : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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....


Condition or disease Intervention/treatment Phase
Prostate Cancer Prosatatic Neoplasm Drug: 18F-DCFPyL Radiation: Tumor Irradiation Radiation: Prostate radiation + tumor boost irradiation Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1/Tumor Irradiation
SBRT will be delivered to areas of recurrent prostatecancer identified on imaging and biopsy
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

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
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: 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




Primary Outcome Measures :
  1. 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.


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


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253744


Contacts
Contact: Theresa Cooley-Zgela, R.N. (240) 760-6207 theresa.cooleyzgela@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03253744     History of Changes
Other Study ID Numbers: 170153
17-C-0153
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 13, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Image Guidance
Dose Escalation
Radiotherapy
Re-irradiation
Quality of Life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases