RECRUITING

A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer

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Conditions

Prostate CancerUnfavorable Intermediate-Risk Prostate CancerStereotactic Body Radiation Therapy (SBRT)21-458

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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 researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments

Official Title

A Phase II Study of Decipher-Guided Dose Escalated Radiation Therapy In Unfavorable Intermediate Risk Prostate Cancer Patients Treated SBRT Alone Without Androgen Deprivation Therapy

Quick Facts

Study Start:2021-12-09
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05169970

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:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment
  2. * Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:
  3. * Gleason Score 4+3
  4. * ≥ 50% biopsy cores positive
  5. * Two or more of the following risk factors:
  6. * Grade Group 2 or 3
  7. * cT2b-T2c
  8. * PSA 10 - 20 ng/mL
  9. * Able to undergo MRI for initial staging and MR based radiation planning
  10. * Sufficient biopsy tissue available for Decipher genomic testing
  11. * Prostate volume \< 90cc
  12. * IPSS ≤ 20
  13. * Age ≥ 18
  14. * KPS ≥ or ECOG 0-2
  15. * Estimated life expectancy \>5 years
  16. * Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
  1. * Radiographic T3-T4 detected on staging mpMRI
  2. * Evidence of distant metastases as determined by MRI, PET, or CT imaging
  3. * Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging
  4. * Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
  5. * Prior pelvic radiation
  6. * Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
  7. * TURP or greenlight PVP within 6 months of enrollment
  8. * History of Crohn's Disease or Ulcerative Colitis

Contacts and Locations

Study Contact

Daniel Gorovets, MD
CONTACT
212-639-3983
gorovetd@mskcc.org
Marisa Kollmeier, MD
CONTACT
212-639-3952

Principal Investigator

Daniel Gorovets, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Daniel Gorovets, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer 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 Date2021-12-09
Study Completion Date2024-12

Study Record Updates

Study Start Date2021-12-09
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Unfavorable Intermediate-Risk Prostate Cancer
  • Stereotactic Body Radiation Therapy (SBRT)
  • 21-458

Additional Relevant MeSH Terms

  • Prostate Cancer