A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-29

Study Completion Date

2025-08-04

Brief Summary

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The purpose of this study is to learn more about what effects the use of high-dose-rate (HDR) brachytherapy on prostate cancer recurrence, seen by AXUMIN PET scan, has on prostate cancer.

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Detailed Description

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In this study the investigator would like to better understand the use of high-dose rate (HDR) brachytherapy to target only recurrent prostate cancer that can be seen by AXUMIN PET scan. The use of HDR brachytherapy for prostate cancer is not new, but it is a more recent advancement to use it to treat only what can be seen instead of the whole prostate.

Conditions

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Prostate Cancer HDR

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: High-Dose-Rate prostate brachytherapy

High-Dose-Rate brachytherapy, 2 fractions

Group Type EXPERIMENTAL

High-Dose-Rate Brachytherapy

Intervention Type PROCEDURE

High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion

Interventions

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High-Dose-Rate Brachytherapy

High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

History of histologically confirmed, clinically localized adenocarcinoma of the prostate treated with external beam radiation, brachytherapy, or combination of external beam radiation and brachytherapy, with curative intent completed at least 24 months ago F-18 fluciclovine (AXUMIN) PET scan within 90 days prior to registration demonstrating recurrent lesion within the prostate gland Biopsy confirmation of disease recurrence within the prostate gland Age ≥ 18 KPS ≥ 70% Suitable candidate for brachytherapy based on established criteria IPSS score \<16 No pelvic arch interference No Rectal fistula/fissure Fit for general or spinal anesthesia No history of urethral stricture Ability to understand, and willingness to sign the written informed consent

Exclusion Criteria

Evidence of metastatic or nodal disease outside of the prostate gland on AXUMIN PET scan within 90 days prior to enrollment Patient unable to have MRI Patients with neuroendocrine or small cell carcinoma of the prostate TURP within 6 months prior to enrollment History of Crohn's disease, ulcerative colitis, or known radiation proctitis Inability to understand spoken and written English

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No