RECRUITING

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

Conditions

Prostate Cancer Prostate Adenocarcinoma Radiation Brachytherapy External beam radiation therapy Androgen Deprivation Therapy ADT EBRT HDR brachytherapy MRI guided brachytherapy brachytherapy boost

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Trial of Combination External Beam Radiation Therapy and MRI-guided, Dose-differentiated High Dose-rate Prostate Brachytherapy Boost for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer

Quick Facts

Study Start:2020-07-30

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04465500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 up to one year before registration. 5. Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4). 6. History and physical exam completed up to 6 months before registration. 7. 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 8. ECOG performance status 0 or 1. 9. Pelvic MRI obtained up to 12 months before registration. 10. Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without ADT. The ADT may have begun prior to study enrollment.	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 up to 6 months (180 days) before registration * Transmural myocardial infarction up to 6 months (180 days) before 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.

Inclusion Criteria

Exclusion 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 up to one year before registration.
5. Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4).
6. History and physical exam completed up to 6 months before registration.
7. 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
8. ECOG performance status 0 or 1.
9. Pelvic MRI obtained up to 12 months before registration.
10. Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without ADT. The ADT may have begun prior to study enrollment.

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 up to 6 months (180 days) before registration
* Transmural myocardial infarction up to 6 months (180 days) before 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.

Contacts and Locations

Study Contact

Song W

CONTACT

434-243-0008

UVARADONCClinicalTrials@uvahealth.org

Principal Investigator

Chris Luminais, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of Virginia

Chris Luminais, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-30

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2020-07-30

Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

Radiation
Brachytherapy
External beam radiation therapy
Androgen Deprivation Therapy
ADT
EBRT
HDR brachytherapy
prostate cancer
MRI guided brachytherapy
brachytherapy boost

Additional Relevant MeSH Terms

Prostate Cancer
Prostate Adenocarcinoma