Prostate Cancer Clinical Trial

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

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.

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Full 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.

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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 is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

12

Study ID:

NCT04645810

Recruitment Status:

Recruiting

Sponsor:

University of Rochester

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There is 1 Location for this study

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University of Rochester
Rochester New York, 14642, United States More Info
Christine Huggins
Contact
585-275-5973
[email protected]
Hong Zhang, MD
Principal Investigator

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Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

12

Study ID:

NCT04645810

Recruitment Status:

Recruiting

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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