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

NCT04465500 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HSR200113
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Adenocarcinoma; Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Compare GU toxicity rate to the rate published in the ASCENDE-RT trial

  Grade 3 GU toxicity rate as measured by CTCAE v5.0

  2 years

Secondary Outcomes (5)

• Estimate the prevalence of grade 3 or greater GU toxicity

  2 years

• Estimate GI and sexual toxicity

  2 years

• Estimate freedom from biochemical failure (RFS)

  5 years

• Estimate rate of undetectable PSA levels

  5 years

• Describe impact of treatment on quality of life

  2 years

Study Arms (1)

Treatment

OTHER

Radiation: External Beam Radiation; Radiation: HDR Brachytherapy; Drug: Androgen Deprivation Therapy

Interventions

External Beam Radiation RADIATION

EBRT will be administered every 5 consecutive days for 5 consecutive weeks. This is standard of care practice for this therapy. This may be revised as applicable per treating physician discretion. The dose of radiation will be in accordance with standard clinical practice guidelines for the treatment of prostate cancer.

Also known as: EBRT

Treatment

HDR Brachytherapy RADIATION

HDR brachytherapy will be administered per standard clinical practice (per NCCN guidelines version 1.2020 for prostate cancer), however standard clinical practice may vary between clinicians. Therefore, the dose of 15Gy in 1 fraction and a set of dosimetry guidelines are to be followed for the purposes of this study. A diagnostic MRI will be co-registered with Transrectal Ultrasound (TRUS) to perform the HDR brachytherapy.

Treatment

Androgen Deprivation Therapy DRUG

The dosing and administration of ADT will be in accordance with the drug label for the drug(s) used for this purpose. Participants may receive ADT before and/or during the course of this study.

Also known as: ADT

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Pelvic MRI obtained up to 12 months before registration.
• Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without ADT. The ADT may have begun prior to study enrollment.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Chris Luminais, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Model Details: Androgen Deprivation Therapy (ADT) High-dose-rate (HDR) Brachytherapy External Beam Radiation Therapy (EBRT)

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: January 30, 2025
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)