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

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

Tracking Information

• First Submitted Date: July 7, 2020
• First Posted Date: July 10, 2020
• Last Update Posted Date: October 27, 2020
• Actual Study Start Date: July 30, 2020
• Estimated Primary Completion Date: January 1, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2

Study Design

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

• Prostate Cancer
• Prostate Adenocarcinoma

Intervention

• 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

Treatment

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 7, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2027
• Estimated Primary Completion Date: January 1, 2027 (Final data collection date for primary outcome measure)

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 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

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Songserea Wood; 434-243-0008; stw2g@hscmail.mcc.virginia.edu

Contact: Amy Smith; (434)243-7231; ajb6bb@hscmail.mcc.virginia.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04465500
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Timothy Showalter, MD, University of Virginia
• Study Sponsor: University of Virginia
• Collaborators: Not Provided

Investigators

• Principal Investigator: Timothy Showalter, MD; University of Virginia

• PRS Account: University of Virginia
• Verification Date: October 2020