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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04465500
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : October 27, 2020
Information provided by (Responsible Party):
Timothy Showalter, MD, University of Virginia

Tracking Information
First Submitted Date  ICMJE July 7, 2020
First Posted Date  ICMJE July 10, 2020
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE July 30, 2020
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
Compare GU toxicity rate to the rate published in the ASCENDE-RT trial [ Time Frame: 2 years ]
Grade 3 GU toxicity rate as measured by CTCAE v5.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • Estimate the prevalence of grade 3 or greater GU toxicity [ Time Frame: 2 years ]
    Greater than or equal to grade 3 GU toxicity rate as measured by CTCAE v5.0
  • Estimate GI and sexual toxicity [ Time Frame: 2 years ]
    GI and sexual toxicity as measured by CTCAE v5.0 and EPIC-26 survey results
  • Estimate freedom from biochemical failure (RFS) [ Time Frame: 5 years ]
    Prostate-specific antigen (PSA) failure (nadir greater than 2ng/mL)
  • Estimate rate of undetectable PSA levels [ Time Frame: 5 years ]
    PSA less than or equal to 0.2ng/mL
  • Describe impact of treatment on quality of life [ Time Frame: 2 years ]
    EPIC-26 survey results
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Androgen Deprivation Therapy (ADT) High-dose-rate (HDR) Brachytherapy External Beam Radiation Therapy (EBRT)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Prostate Adenocarcinoma
Intervention  ICMJE
  • 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 Name: 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 Name: ADT
Study Arms  ICMJE Treatment
  • Radiation: External Beam Radiation
  • Radiation: HDR Brachytherapy
  • Drug: Androgen Deprivation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2027
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 completed up to 6 months before registration.
  7. PSA value < 50 ng/mL prior to androgen deprivation therapy and up to 6 months before registration
  8. ECOG performance status 0 or 1.
  9. Pelvic MRI obtained up to 6 months before registration.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Songserea Wood 434-243-0008
Contact: Amy Smith (434)243-7231
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04465500
Other Study ID Numbers  ICMJE HSR200113
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy Showalter, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy Showalter, MD University of Virginia
PRS Account University of Virginia
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP