N/A
N=11
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7 · Stage II Prostate Adenocarcinoma AJCC v7 · Stage III Prostate Adenocarcinoma AJCC v7
Bottom Line
View on ClinicalTrials.gov: NCT02830165 ↗Enrolled (actual)
11
Serious AEs
18.2%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboratory Biomarker Analysis (Other); Quality-of-Life Assessment (Other); Stereotactic Body Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Jonsson Comprehensive Cancer Center
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications |
11 | — |
| SECONDARY Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities |
1; 4; 4; 2; 9; 1 | — |
| SECONDARY Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring. |
-32.8; -1.6; -2.1; -34.4; -10.6 | — |
| SECONDARY Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire. |
0.5 | — |
| SECONDARY Correlative Biomarker Analyses Using Tissue and Serial Blood Samples |
70; 30; 110; 90; 30; 50 | — |
Summary
This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Patient desires and is medically fit to undergo prostatectomy
- Karnofsky performance status (KPS) >= 70
- Patients on androgen deprivation therapy (ADT) are allowed
- For confirmation of high risk local failure status, patients will have any one of the following:
- Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
- Pre-biopsy prostate-specific antigen (PSA) >= 20
- Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
- Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
- Clinical stage >= T3 (staging by imaging acceptable)
- An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy
Exclusion Criteria
- Distant metastases, based upon:
- CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
- Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
- Patient is unable or unwilling to sign consent
- Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
Data sourced from ClinicalTrials.gov (NCT02830165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.