EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer (Prostate005)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer; Prostate Adenocarcinoma
• Intervention / Treatment: Radiation: External Beam Radiation; Radiation: HDR Brachytherapy; Drug: Androgen Deprivation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Treatment

Radiation: External Beam 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.; Other Names: EBRT; Radiation: HDR Brachytherapy; 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.; Drug: Androgen Deprivation Therapy; 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.; Other Names: ADT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the prevalence of grade 3 or greater GU toxicity	Greater than or equal to grade 3 GU toxicity rate as measured by CTCAE v5.0	2 years
Estimate GI and sexual toxicity	GI and sexual toxicity as measured by CTCAE v5.0 and EPIC-26 survey results	2 years
Estimate freedom from biochemical failure (RFS)	Prostate-specific antigen (PSA) failure (nadir greater than 2ng/mL)	5 years
Estimate rate of undetectable PSA levels	PSA less than or equal to 0.2ng/mL	5 years
Describe impact of treatment on quality of life	EPIC-26 survey results	2 years

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Chris Luminais, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2029

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer; Brachytherapy; Androgen Deprivation Therapy; ADT; Radiation; External beam radiation therapy; EBRT; HDR brachytherapy; brachytherapy boost; MRI guided brachytherapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Pharmacologic Actions; Chemical Actions and Uses; Androgen Antagonists
• Other Study ID Numbers: HSR200113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No