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

Primary Purpose

Locally Recurrent Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HDR Brachytherapy

About this trial

This is an interventional treatment trial for Locally Recurrent Prostate Cancer focused on measuring Cancer, HDR Brachytherapy, Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Loyola University Medical CenterRecruiting
University of Virginia School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HDR Brachytherapy

Arm Description

HDR Brachytherapy implant, Up to 30 Gray (Gy) to target lesion in one to two fractions.

Outcomes

Primary Outcome Measures

Toxicity rate

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03312972

First Posted

September 22, 2017

Last Updated

May 29, 2020

Sponsor

Loyola University

1. Study Identification

Unique Protocol Identification Number

NCT03312972

Brief Title

Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

Acronym

F-Sharp

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Recruiting

Study Start Date

August 28, 2017 (Actual)

Primary Completion Date

March 31, 2022 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Recurrent Prostate Cancer

Keywords

Cancer, HDR Brachytherapy, Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HDR Brachytherapy

Arm Type

Experimental

Arm Description

HDR Brachytherapy implant, Up to 30 Gray (Gy) to target lesion in one to two fractions.

Intervention Type

Radiation

Intervention Name(s)

HDR Brachytherapy

Intervention Description

HDR Brachytherapy implant, deliver 1 to 2 fractions, Up to 30 Gray (Gy) to target lesion

Primary Outcome Measure Information:

Title

Toxicity rate

Description

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.

Time Frame

24 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Chiappetta, BSN

Phone

708-216-2568

bchiappetta@lumc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Abhishek Solanki, MD

Phone

708-216-2556

Abhishek.Solanki@lumc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abhishek Solanki, MD

Organizational Affiliation

Loyola University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Chiappetta, BSN

Phone

708-216-2568

bchiappetta@lumc.edu

First Name & Middle Initial & Last Name & Degree

Abhishek Solanki, MD

Phone

708-216-2556

abhishek.solanki@lumc.edu

First Name & Middle Initial & Last Name & Degree

Abhishek Solanki, MD

First Name & Middle Initial & Last Name & Degree

Matt Harkenrider, MD

First Name & Middle Initial & Last Name & Degree

Murat Surucu, PhD

First Name & Middle Initial & Last Name & Degree

Michael Mysz, MS

First Name & Middle Initial & Last Name & Degree

Hyejoo Kang, PhD

First Name & Middle Initial & Last Name & Degree

Gopal Gupta, MD

First Name & Middle Initial & Last Name & Degree

Robert Flanigan, MD

First Name & Middle Initial & Last Name & Degree

Ahmer Farooq, DO

First Name & Middle Initial & Last Name & Degree

Kristin Baldea, MD

First Name & Middle Initial & Last Name & Degree

Steven Shea, PhD

First Name & Middle Initial & Last Name & Degree

Courtney Hentz, MD

First Name & Middle Initial & Last Name & Degree

Mark Korpics, MS

Facility Name

University of Virginia School of Medicine

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy Showalter, MD, MPH

Phone

434-982-6278

tns3b@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

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Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

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