Prostate Cancer
Conditions
Keywords
Unfavorable Intermediate-Risk Prostate Cancer, Stereotactic Body Radiation Therapy (SBRT), 21-458
Brief 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
Interventions
RADIATIONStereotactic Body Radiation Therapy (SBRT)
Patients with a low or intermediate risk Decipher score will receive radiation targeting the seminal prostate and seminal vesicles to a dose of 40 Gy in 5 fractions delivered every other day.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a phase II nonrandomized noninferiority trial that aims to evaluate the efficacy of dose escalated radiation therapy in the absence of androgen deprivation therapy for Decipher genomic score stratified NCCN unfavorable intermediate risk prostate cancer.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Radiographic T3-T4 detected on staging mpMRI °Must be "consistent with" (\>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist. * Evidence of distant metastases as determined by MRI, PET, or CT imaging * Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging * Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy * Prior pelvic radiation * 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 * TURP or greenlight PVP within 6 months of enrollment * History of Crohn's Disease or Ulcerative Colitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of biochemical progression free survival | 2 years | Biochemical progression will be determined according to the established criteria of 2 ng/nl elevation of the PSA nadir level (nadir + 2 definition). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Gorovets, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed