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

Clinicaltrials.gov ID: NCT04645810
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 12

Conditions

Prostate Cancer, HDR

Summary

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.

Detailed Description

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Hong Zhang

Eligibility Criteria

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

Study Plan

Experimental: High-Dose-Rate prostate brachytherapy

EXPERIMENTAL

High-Dose-Rate brachytherapy, 2 fractions

  • PROCEDURE:

    High-Dose-Rate Brachytherapy

    Description:

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

Outcome Measures

Primary Outcome Measures

Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above

Time Frame: 6 Months

Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

Time Frame: 6 Months

Secondary Outcome Measures

Progression Free Survival

Time Frame: 6 Months

Timeline

  • Last Updated
    August 6, 2024
  • Start Date
    November 27, 2020
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    May 31, 2027

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