High-dose-rate brachytherapy for recurrent prostate cancer
A Pilot Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
This study is testing a new way to treat recurrent prostate cancer by using high-dose-rate brachytherapy to target only the cancer spots seen on special scans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04645810 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effects of high-dose-rate (HDR) brachytherapy specifically targeting recurrent prostate cancer lesions identified through AXUMIN PET scans. The approach focuses on treating only the visible recurrent cancer rather than the entire prostate, which is a more recent advancement in prostate cancer treatment. Participants will undergo HDR brachytherapy after meeting specific eligibility criteria, including prior treatment history and confirmation of disease recurrence. The study seeks to gather data on the efficacy and safety of this targeted treatment method.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with a history of localized prostate cancer who have experienced recurrence within the prostate gland as confirmed by an AXUMIN PET scan.
Not a fit: Patients with evidence of metastatic disease outside the prostate or those unable to undergo MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less invasive option for patients with recurrent prostate cancer.
How similar studies have performed: While HDR brachytherapy has been used in prostate cancer treatment, this specific approach targeting only visible recurrences is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Hong Zhang — University of Rochester Wilmot Cancer Center
- Study coordinator: Therese Smudzin
- Email: therese_smudzin@urmc.rochester.edu
- Phone: 5852757848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.