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study stopped early, did not enroll anyone, and will not resume
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: High-Dose-Rate prostate brachytherapy | Experimental | High-Dose-Rate brachytherapy, 2 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose-Rate Brachytherapy | Procedure | High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above | 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 | 6 Months |
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | Measured by adverse event severity and quantity | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Measure of time from study enrollment until progression. | 6 Months |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang | University of Rochester Wilmot Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |