Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy (F-Sharp)

May 29, 2020 updated by: Abhishek A. Solanki, Loyola University

F-SHARP: A Phase I/II Trial of Focal Salvage High-dose-rate BRachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

This purpose of this study is to evaluate the safety and effectiveness of a technique called focal high-dose-rate (HDR) brachytherapy as treatment for prostate cancer that has come back in the prostate after prior radiotherapy. The study will examine the safety and efficacy of the treatment. The type of radiation that participants in this research will receive is targeted directly at the areas of the prostate where recurrent disease is evident, while avoiding treatment of the normal appearing prostate. This involves the placement of a radioactive material in the affected area of the prostate temporarily, where it remains for a short period of time, and then is subsequently removed using a minimally invasive technique called HDR Brachytherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of any radiation treatment plan is to achieve maximal disease response with minimal toxicity. HDR brachytherapy offers a promising definitive treatment option in the setting of Locally Recurrent Prostate Cancer after prior definitive radiation, based on the limited data described above, with achievement of biochemical disease control in a large percentage of patients with relatively low toxicity. With focal HDR brachytherapy, the investigators can treat the isolated areas of disease, while avoiding normal prostate tissue, with the goal of further improving toxicity rates. The investigators hypothesize that using single fraction, focal HDR brachytherapy performed with one single implant for the treatment of LRPC is feasible and without excess toxicity, and can be safely delivered. This should allow for better patient convenience and cost and improved treatment dosimetry and planning, as it will decrease the risk of catheter displacement between fractions, which will hopefully correlate to less GU and non-GU acute toxicity. The primary objective is to determine the acute and late GU and GI toxicity of single fraction focal HDR salvage brachytherapy (primary endpoint).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
        • Sub-Investigator:
          • Matt Harkenrider, MD
        • Sub-Investigator:
          • Murat Surucu, PhD
        • Sub-Investigator:
          • Michael Mysz, MS
        • Sub-Investigator:
          • Hyejoo Kang, PhD
        • Sub-Investigator:
          • Gopal Gupta, MD
        • Sub-Investigator:
          • Steven Shea, PhD
        • Sub-Investigator:
          • Courtney Hentz, MD
        • Sub-Investigator:
          • Mark Korpics, MS
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Not yet recruiting
        • University of Virginia School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.

    • Biopsy must be performed within 182 days of trial registration
    • Biopsy should be a standard sextant biopsy AND either a targeted MR/ultrasound guided biopsy or saturation biopsy or both.

  • Initial cancer diagnosis that fits these specific criteria:

    • Stages T1-T3a
    • Nx or N0
    • Mx or M0
  • Eligible initial definitive radiotherapy modalities include:

  • External beam radiotherapy, with photon or proton beam therapy

    • Conventional or moderately hypofractionated radiotherapy
    • Extremely hypofractionated external beam radiotherapy (Stereotactic body radiation therapy)

  • Definitive Brachytherapy:

    • Low-dose rate
    • High-dose rate

  • Locally recurrent disease confined to the prostate +/- seminal vesicles and immediately adjacent tissue, as evaluated by the following:

    • History/Physical examination
    • Radiographically node negative disease (N0), as defined by CT or MR of pelvis +/- abdomen within 6 months of registration.
    • No evidence of bone metastases (M0) on bone scan within 6 months of registration.
    • Fluciclovine-PET is encouraged, but not required
  • Patients receiving ADT are eligible as long as they meet the other eligibility criteria. However, the duration of all ADT must be documented.
  • Current ECOG Performance status Scale 0-2
  • Current International Prostate Symptom Score (IPSS) < 20
  • The patient must be medically suitable to receive general anesthesia.
  • The patient must be able and willing to sign a study-specific written informed consent form before study entry.

Exclusion Criteria:

  • Preregistration GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
  • Patients receiving any other investigational agents.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
  • Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HDR Brachytherapy
HDR Brachytherapy implant, Up to 30 Gray (Gy) to target lesion in one to two fractions.
Radiation: HDR Brachytherapy
HDR Brachytherapy implant, deliver 1 to 2 fractions, Up to 30 Gray (Gy) to target lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity rate
Time Frame: 24 months
The primary outcome in this study is the number of acute or chronic grade 3-5 toxicities as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Abhishek Solanki, MD, Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2017

Primary Completion (ANTICIPATED)

March 31, 2022

Study Completion (ANTICIPATED)

March 31, 2024

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (ACTUAL)

October 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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