EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer (NCT04465500) | Clinical Trial Compass
Active — Not RecruitingPhase 2
EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer
United States60 participantsStarted 2025-01-30
Plain-language summary
This study is trying to find out if the combination of Androgen deprivation therapy (ADT), MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects. This study is also looking at patient outcomes, quality of life, and overall survival for patients receiving this treatment.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provision of signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male, aged 18 or above.
✓. Histologic proven diagnosis of cancer of the prostate up to one year before registration.
✓. Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4).
✓. History and physical exam completed up to 6 months before registration.
✓. PSA value \< 50 ng/mL prior to androgen deprivation therapy and up to 12 months before registration. Subjects who do not meet this criteria's timeframe due to extenuating circumstances (i.e. COVID-19 quarantine, changes to their treatment plan, etc) but meet all other eligibility criteria may still be eligible. The PI will review each case and decide
✓. ECOG performance status 0 or 1.
Exclusion criteria
✕. Evidence of bone metastases.
✕. Diagnosis of a prior invasive malignancy (except for non-melanoma skin cancer), unless the participant has been disease-free for at least 3 years.
✕. Patient has had previous radical surgery (prostatectomy) or cryosurgery for prostate cancer.
What they're measuring
1
Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
. Patient has had previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy.
✕. Patient has had prior radiotherapy, including brachytherapy, to the region of this study cancer that would result in overlap of radiation therapy fields.
✕. Patient has had previous or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for different cancer is allowed).
✕. Patient has MRI incompatible metallic implant(s) that cannot be removed.
✕. The patient has severe or active co-morbidities as defined by the following: