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EBRT and HDR Brachytherapy for Unfavorable-intermediate High and Very High-risk Prostate Cancer

EBRT and HDR Brachytherapy for Unfavorable-intermediate High and Very High-risk Prostate Cancer

Recruiting
18 years and older
Male
Phase 2

Overview

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.

Eligibility

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male, aged 18 or above.
  4. Histologic proven diagnosis of cancer of the prostate within one year of registration.
  5. Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019.
  6. History and physical exam (including digital rectal exam) completed within 60 days of registration.
  7. PSA value < 50 ng/mL.
  8. ECOG performance status 0 or 1.

Exclusion Criteria:

  1. Evidence of bone metastases.
  2. Diagnosis of a prior invasive malignancy (except for non-melanoma skin cancer), unless the participant has been disease-free for at least 3 years.
  3. Patient has had previous radical surgery (prostatectomy) or cryosurgery for prostate cancer.
  4. Patient has had previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy.
  5. Patient has had prior radiotherapy, including brachytherapy, to the region of this study cancer that would result in overlap of radiation therapy fields.
  6. Patient has had previous or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for different cancer is allowed).
  7. Patient has MRI incompatible metallic implant(s) that cannot be removed.
  8. The patient has severe or active co-morbidities as defined by the following:
    • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months (180 days) of registration
    • Transmural myocardial infarction within 6 months (180 days) of registration
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction.
    • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

Study details
    Malignant neoplasm of prostate
    Prostatic disorder
    Prostate Adenocarcinoma

NCT04465500

University of Virginia

16 February 2024

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