Clinical Trials /

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

NCT04465500

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: HSR200113
  • NCT ID: NCT04465500

Conditions

  • Prostate Cancer
  • Prostate Adenocarcinoma

Interventions

DrugSynonymsArms
Androgen Deprivation TherapyADTTreatment

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TreatmentOther
  • Androgen Deprivation Therapy

Eligibility Criteria

        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 within one year of registration.

          5. Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as
             determined by the NCCN Guidelines Version 4.2019.

          6. History and physical exam (including digital rectal exam) completed within 60 days of
             registration.

          7. PSA value < 50 ng/mL.

          8. ECOG performance status 0 or 1.

        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 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
Time Frame:2 years
Safety Issue:
Description:Grade 3 GU toxicity rate as measured by CTCAE v5.0

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Virginia

Trial Keywords

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

Last Updated

July 22, 2020