Prostate Cancer Clinical Trial

RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy

Summary

This study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.

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Full Description

This study offers focal stereotactic body radiotherapy for prostate cancer by using an intra-urethral radiotransponder placed temporarily during each of the 5 radiotherapy treatments. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time while also accessing early efficacy, late toxicity, and overall quality of life post-treatment. Patients will be followed for 24 months (2 years) with follow-up appointments at 3, 6, 9, 12, 18, and 24 months.

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Eligibility Criteria

Inclusion Criteria:

All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration

Gleason score 3+3 or 3+4
PSA <10 ng/mL within 3 months of enrollment
Clinical stage T1a-T2a by digital rectal exam
Up to 2 intraprostatic nodules visible on MRI, with combined volume <50% of the total prostate volume
Karnofsky Performance Status (KPS) >70%.
Life expectancy >10 years
Age ≥ 19 years
Subjects given written informed consent

Exclusion Criteria:

>2 MRI defined nodules representing prostate cancer
Total volume of MRI nodules exceeding 50% of total prostate volume
Positive biopsy core in sextant region without MRI defined nodule (i.e. biopsy proven MRI occult prostate cancer)
American Urological Association (AUA) urinary score ≥ 18.
History of inflammatory bowel disease.
Prior pelvic surgery
Prior treatment for prostate cancer
Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria.
Platelet count < 70,000/µL
Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
Contraindication to MRI such as implanted devices.
Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT

Study is for people with:

Prostate Cancer

Estimated Enrollment:

5

Study ID:

NCT03458234

Recruitment Status:

Terminated

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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Hazelrig-Salter Radiation Oncology Center
Birmingham Alabama, 35233, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

5

Study ID:

NCT03458234

Recruitment Status:

Terminated

Sponsor:


University of Alabama at Birmingham

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