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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.
 
ClinicalTrials.gov Identifier: NCT04465500
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy Showalter, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Radiation: External Beam Radiation Radiation: HDR Brachytherapy Drug: Androgen Deprivation Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
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
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Estimate GI and sexual toxicity [ Time Frame: 2 years ]
    GI and sexual toxicity as measured by CTCAE v5.0 and EPIC-26 survey results

  3. Estimate freedom from biochemical failure (RFS) [ Time Frame: 5 years ]
    Prostate-specific antigen (PSA) failure (nadir greater than 2ng/mL)

  4. Estimate rate of undetectable PSA levels [ Time Frame: 5 years ]
    PSA less than or equal to 0.2ng/mL

  5. Describe impact of treatment on quality of life [ Time Frame: 2 years ]
    EPIC-26 survey results



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465500


Contacts
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Contact: Songserea Wood 434-243-0008 stw2g@hscmail.mcc.virginia.edu
Contact: Amy Smith (434)243-7231 ajb6bb@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Songserea Wood         
Contact: Amy Smith         
Principal Investigator: Timothy Showalter, MD         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Timothy Showalter, MD University of Virginia
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Responsible Party: Timothy Showalter, MD, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT04465500    
Other Study ID Numbers: HSR200113
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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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
Keywords provided by Timothy Showalter, MD, University of Virginia:
Radiation
Brachytherapy
External beam radiation therapy
Androgen Deprivation Therapy
ADT
EBRT
HDR brachytherapy
prostate cancer
MRI guided brachytherapy
brachytherapy boost
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs