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

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Stereotactic Body Radiation Therapy (SBRT)
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment

• Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:

• Gleason Score 4+3

• ≥ 50% biopsy cores positive

• Two or more of the following risk factors:

‣ Grade Group 2 or 3

⁃ cT2b-T2c

⁃ PSA 10 - 20 ng/mL

• Able to undergo MRI for initial staging and MR based radiation planning

• Sufficient biopsy tissue available for Decipher genomic testing

• Prostate volume \< 90cc

• IPSS ≤ 20

• Age ≥ 18

• KPS ≥ or ECOG 0-2

• Estimated life expectancy \>5 years

• Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Daniel Gorovets, MD
gorovetd@mskcc.org
212-639-3983
Backup
Marisa Kollmeier, MD
212-639-3952
Time Frame
Start Date: 2021-12-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 215
Treatments
Experimental: Patients with low-intermediate risk Decipher scores
Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).
Experimental: Patients with high risk Decipher scores
Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions) with a boost of up to 45Gy to the dominant intraprostatic lesion as identified on pretreatment MRI plus hypofractionated pelvic EBRT (25Gy in 5 fractions).
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov