Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Unfavorable Intermediate-Risk Prostate Cancer
This phase II trial tests whether stereotactic body radiation therapy (SBRT) works to shrink tumors in patients with unfavorable intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Inclusion Criteria
- Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment.
- Unfavorable intermediate risk prostate cancer by The National Comprehensive Cancer Network (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 ** Prostate-specific antigen (PSA) 10 – 20 ng/mL
- Able to undergo magnetic resonance imaging (MRI) for initial staging and MR based radiation planning.
- Sufficient biopsy tissue available for Decipher genomic testing.
- Prostate volume < 90 cc.
- IPSS =< 20.
- Age >= 18.
- Karnofsky performance status (KPS) >= or Eastern Cooperative Oncology Group (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 multiparametric magnetic resonance imaging (mpMRI) * Must be “consistent with” (>90% probability) or suspicious for/probable/probably (75%-90% probability) of T3-T4 disease determined by the reading radiologist.
- Evidence of distant metastases as determined by magnetic resonance imaging (MRI), positron emission tomography (PET), or computed tomography (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.
- Transurethral prostatic resection (TURP) or greenlight photoselective vaporization of the prostate (PVP) within 6 months of enrollment.
- History of Crohn’s disease or Ulcerative Colitis.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05169970.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Middletown
Montvale
New York
Commack
New York
Uniondale
West Harrison
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of Decipher guided dose escalated radiation therapy in unfavorable intermediate risk prostate cancer patients with low-intermediate Decipher score treated without androgen deprivation therapy by assessing 5-year biochemical progression free survival (biochemical progression defined as prostate specific antigen [PSA] nadir + 2ng/mL).
II. Evaluate the efficacy of Decipher guided dose escalated radiation therapy in unfavorable intermediate risk prostate cancer patients with high Decipher score treated without androgen by assessing 5-year biochemical progression free survival (biochemical progression defined as PSA nadir + 2ng/mL).
SECONDARY OBJECTIVES:
I. Two-year biochemical progression free survival, two-year post-treatment positive biopsy rate, two-year metastasis rate, and two-year prostate cancer specific mortality rate.
II. Evaluate acute and late physician-scored toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
III. Evaluate patient-reported quality of life outcomes using International prostate symptom score index (IPSS), International Index of Erectile Function (IIEF), The Expanded Prostate Cancer Index Composite Short Form (EPIC-26).
OUTLINE:
Patients undergo SBRT over 45 minutes every other day for 10 days. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT), bone scans, and/or positron emission tomography (PET) scan during screening.
After completion of study treatment, patients are followed up at 3, 6, 12, 24, 36, 48, and 60 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorDaniel Gorovets
- Primary ID21-458
- Secondary IDsNCI-2022-00072
- ClinicalTrials.gov IDNCT05169970