F-Sharp: Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Toxicity rate [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
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Biopsy must be performed within 182 days of trial registration
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Biopsy should be a standard sextant biopsy AND either a targeted MR/ultrasound guided biopsy or saturation biopsy or both.
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Initial cancer diagnosis that fits these specific criteria:
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Stages T1-T3a
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Nx or N0
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Mx or M0
-
Eligible initial definitive radiotherapy modalities include:
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External beam radiotherapy, with photon or proton beam therapy
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Conventional or moderately hypofractionated radiotherapy
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Extremely hypofractionated external beam radiotherapy (Stereotactic body radiation therapy)
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Definitive Brachytherapy:
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Low-dose rate
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High-dose rate
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Locally recurrent disease confined to the prostate +/- seminal vesicles and immediately adjacent tissue, as evaluated by the following:
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History/Physical examination
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Radiographically node negative disease (N0), as defined by CT or MR of pelvis +/- abdomen within 6 months of registration.
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No evidence of bone metastases (M0) on bone scan within 6 months of registration.
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Fluciclovine-PET is encouraged, but not required
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Patients receiving ADT are eligible as long as they meet the other eligibility criteria. However, the duration of all ADT must be documented.
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Current ECOG Performance status Scale 0-2
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Current International Prostate Symptom Score (IPSS) < 20
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The patient must be medically suitable to receive general anesthesia.
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The patient must be able and willing to sign a study-specific written informed consent form before study entry.
Exclusion Criteria:
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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
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Patients receiving any other investigational agents.
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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.
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Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 2 | University of Virginia School of Medicine | Charlottesville | Virginia | United States | 22908 |
Sponsors and Collaborators
- Loyola University
Investigators
- Principal Investigator: Abhishek Solanki, MD, Loyola University
Study Documents (Full-Text)
None provided.More Information
Publications
- Ahmadi H, Daneshmand S. Androgen deprivation therapy for prostate cancer: long-term safety and patient outcomes. Patient Relat Outcome Meas. 2014 Jul 5;5:63-70. doi: 10.2147/PROM.S52788. eCollection 2014. Review.
- Beyer DC. Permanent brachytherapy as salvage treatment for recurrent prostate cancer. Urology. 1999 Nov;54(5):880-3.
- Chen CP, Weinberg V, Shinohara K, Roach M 3rd, Nash M, Gottschalk A, Chang AJ, Hsu IC. Salvage HDR brachytherapy for recurrent prostate cancer after previous definitive radiation therapy: 5-year outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):324-9. doi: 10.1016/j.ijrobp.2013.01.027. Epub 2013 Mar 6.
- Grado GL, Collins JM, Kriegshauser JS, Balch CS, Grado MM, Swanson GP, Larson TR, Wilkes MM, Navickis RJ. Salvage brachytherapy for localized prostate cancer after radiotherapy failure. Urology. 1999 Jan;53(1):2-10.
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- Wirth MP, Hakenberg OW, Froehner M. Antiandrogens in the treatment of prostate cancer. Eur Urol. 2007 Feb;51(2):306-13; discussion 314. Epub 2006 Sep 11. Review.
- Yamada Y, Kollmeier MA, Pei X, Kan CC, Cohen GN, Donat SM, Cox BW, Zelefsky MJ. A Phase II study of salvage high-dose-rate brachytherapy for the treatment of locally recurrent prostate cancer after definitive external beam radiotherapy. Brachytherapy. 2014 Mar-Apr;13(2):111-6. doi: 10.1016/j.brachy.2013.11.005. Epub 2013 Dec 25.
- Zelefsky MJ, Kuban DA, Levy LB, Potters L, Beyer DC, Blasko JC, Moran BJ, Ciezki JP, Zietman AL, Pisansky TM, Elshaikh M, Horwitz EM. Multi-institutional analysis of long-term outcome for stages T1-T2 prostate cancer treated with permanent seed implantation. Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):327-33. Epub 2006 Nov 2.
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