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

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Updated on 19 February 2024

See if I qualify

cancer

adenocarcinoma

prostate adenocarcinoma

androgens

pelvic mri

brachytherapy

digital rectal examination

external beam radiation therapy

digital rectal exam

antiandrogen therapy

adenocarcinoma of prostate

androgen suppression

prostate cancer

Summary

Show definitions

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, Prostatic disorder, Prostate Adenocarcinoma
Age	18years - 100years
Treatment	External Beam Radiation, HDR Brachytherapy, Androgen Deprivation Therapy
Clinical Study Identifier	NCT04465500
Sponsor	University of Virginia
Last Modified on	19 February 2024

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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 (including digital rectal exam) completed within 60 days of registration
	PSA value < 50 ng/mL
	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
	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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EBRT and HDR Brachytherapy for Unfavorable-intermediate High and Very High-risk Prostate Cancer