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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2027
  • participants needed
    60
  • sponsor
    University of Virginia
Updated on 26 January 2021
cancer
androgens
antiandrogen therapy
androgen suppression
brachytherapy
external beam radiation therapy
digital rectal exam
digital rectal examination

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.

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Prostatic disorder, Prostate Disorders, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Adenocarcinoma, Adenocarcinoma of the Prostate, Adenocarcinoma of Prostate, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Androgen Deprivation Therapy, External beam radiation, HDR Brachytherapy
Clinical Study IdentifierNCT04465500
SponsorUniversity of Virginia
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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 within one year of registration
Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019
History and physical exam completed up to 6 months before registration
PSA value < 50 ng/mL prior to androgen deprivation therapy and up to 6 months before registration
ECOG performance status 0 or 1
Pelvic MRI obtained up to 6 months before registration

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
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
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
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