Clinical Trials /

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

NCT04645810

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
  • Official Title: A Pilot Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence

Clinical Trial IDs

  • ORG STUDY ID: UGUP20045
  • NCT ID: NCT04645810

Conditions

  • Prostate Cancer
  • HDR

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Experimental: High-Dose-Rate prostate brachytherapyExperimentalHigh-Dose-Rate brachytherapy, 2 fractions

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above
    Time Frame:6 Months
    Safety Issue:
    Description:Rate of prostate-specific antigen (PSA) failure after focal salvage HDR in the setting of prostate only recurrence after primary non-surgical treatment, defined as a PSA rise of 2 ng/ml or more above the nadir at 6 months

    Secondary Outcome Measures

    Measure:Progression Free Survival
    Time Frame:6 Months
    Safety Issue:
    Description:Measure of time from study enrollment until progression.

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:University of Rochester

    Trial Keywords

    • Brachytherapy
    • Prostate Cancer
    • High-Dose-Rate (HDR)

    Last Updated

    December 2, 2020