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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    50
  • sponsor
    Loyola University
Updated on 24 January 2021

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.

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).

Details
Condition Locally Recurrent Prostate Cancer
Treatment HDR Brachytherapy
Clinical Study IdentifierNCT03312972
SponsorLoyola University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Locally Recurrent Prostate Cancer?
Do you have any of these conditions: Do you have Locally Recurrent Prostate Cancer??
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
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