Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy (F-Sharp)
|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: NCT03312972|
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : June 2, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Locally Recurrent Prostate Cancer||Radiation: HDR Brachytherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 28, 2017|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2024|
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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
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)
- 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.
- 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
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): NCT03312972
|Contact: Beth Chiappetta, BSNemail@example.com|
|Contact: Abhishek Solanki, MD||708-216-2556||Abhishek.Solanki@lumc.edu|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Beth Chiappetta, BSN 708-216-2568 firstname.lastname@example.org|
|Contact: Abhishek Solanki, MD 708-216-2556 email@example.com|
|Principal Investigator: Abhishek Solanki, MD|
|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: Robert Flanigan, MD|
|Sub-Investigator: Ahmer Farooq, DO|
|Sub-Investigator: Kristin Baldea, MD|
|Sub-Investigator: Steven Shea, PhD|
|Sub-Investigator: Courtney Hentz, MD|
|Sub-Investigator: Mark Korpics, MS|
|United States, Virginia|
|University of Virginia School of Medicine||Not yet recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Timothy Showalter, MD, MPH 434-982-6278 firstname.lastname@example.org|
|Principal Investigator:||Abhishek Solanki, MD||Loyola University|
|Responsible Party:||Abhishek A. Solanki, Assistant Professor of Radiation Oncology, Loyola University|
|Other Study ID Numbers:||
|First Posted:||October 18, 2017 Key Record Dates|
|Last Update Posted:||June 2, 2020|
|Last Verified:||May 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||There is no plan to make individual participant data (IPD) available to other researchers|
|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|
Genital Neoplasms, Male
Neoplasms by Site