SUSPENDED

Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device

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Conditions

ProstateCancerRadiationTheraSphereY90Yttrium-90GlassMicrospheres

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The VOYAGER Study is an interventional, non-randomized, single-arm, dose escalation trial with the goal of determining the safety of TheraSphere PCa device in patients with clinically localized prostate cancer across US-based centers.

Official Title

An Early Feasibility Study to Evaluate the Safety of the TheraSphere Prostate Cancer (PCa) Device in Patients With Clinically Localized Prostate Cancer

Quick Facts

Study Start:2024-04-15
Study Completion:2032-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT06192758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has ability to comprehend and willingness to sign and date the IRB-approved study informed consent form (ICF), and to comply with the study testing, procedures, and follow-up schedule.
  2. 2. Histologic confirmation of adenocarcinoma of the prostate by MR-fusion biopsy. Referral biopsy for eligibility must be completed between 180 days and 6 weeks prior to mapping procedure.
  3. 3. Subject with favorable intermediate risk clinically localized prostate cancer defined per NCCN Guidelines version 3.2022 as follows:
  4. * Favorable intermediate-risk has all the following:
  5. * i. One Intermediate Risk Factor (IRF):
  6. 1. cT2b-cT2c
  7. 2. Grade Group 2 or 3
  8. 3. PSA 10-20 ng/mL
  9. * ii. Grade Group 1 or 2
  10. * iii. \<50% biopsy cores positive (e.g., \<6 of 12 cores)
  11. 4. Staging MRI must confirm American Joint Committee on Cancer (AJCC, 8th edition) stage T1, T2a, T2b or T2c.
  12. 5. Whole prostate gland volume ≥ 60 cc (measured on MRI)
  13. 6. International Prostate Score Symptom (I-PSS) ≤ 18
  14. 7. Estimated life expectancy of \>5 years according to NCCN guideline's tools (NCCN v03.2022) who has declined or is ineligible for Standard of Care treatments (observation, active surveillance, surgery, and radiation therapies \[brachytherapy/external beam radiation therapy\])
  15. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  16. 9. Angiographic
  1. 1. Direct evidence of regional or distant metastases after appropriate staging studies per NCCN guidelines (v03.2022)
  2. 2. Histological evidence of intraductal features
  3. 3. Previous treatments (pelvic radiotherapy, surgery, prostate artery embolization \[PAE\], transurethral resection of the prostate \[TURP\] or previous/ planned hormonal therapy
  4. 4. History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia, current gross haematuria, or current urinary catheter
  5. 5. Subjects with ongoing urinary tract infection, prostate abscess, prostatitis, or neurogenic bladder
  6. 6. Prior significant rectal surgery (haemorrhoidectomy is acceptable)
  7. 7. Prior invasive malignancy unless disease free for a minimum of 3 years. Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease
  8. 8. Hip prosthesis
  9. 9. Medical contraindication to undergo contrast-enhanced angiography, CT scan and magnetic resonance imaging (MRI), or arterial catheterization, or known history of hypersensitivity reactions to iodinated and gadolinium-based contrast product
  10. 10. Angiographic

Contacts and Locations

Principal Investigator

Samdeep Mouli, M.D., M.S.
PRINCIPAL_INVESTIGATOR
Northwestern Medical Hospital
Mark Hurwitz, MD
PRINCIPAL_INVESTIGATOR
Westchester Medical Center

Study Locations (Sites)

Ronald Reagan UCLA Medical Center (UCLA Health, Los Angeles)
Los Angeles, California, 90095
United States
University of Miami (Sylvester Comprehensive Cancer Center)
Miami, Florida, 33136
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Mount Sinai Hospital
New York, New York, 10022
United States
Weill Cornell Medicine
New York, New York, 10075
United States

Collaborators and Investigators

Sponsor: Boston Scientific Corporation

  • Samdeep Mouli, M.D., M.S., PRINCIPAL_INVESTIGATOR, Northwestern Medical Hospital
  • Mark Hurwitz, MD, PRINCIPAL_INVESTIGATOR, Westchester Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-15
Study Completion Date2032-10

Study Record Updates

Study Start Date2024-04-15
Study Completion Date2032-10

Terms related to this study

Keywords Provided by Researchers

  • Radiation
  • TheraSphere
  • Y90
  • Yttrium-90
  • Glass
  • Microspheres

Additional Relevant MeSH Terms

  • Prostate
  • Cancer