Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7
- Sponsor
- Jonsson Comprehensive Cancer Center
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
PRIMARY OBJECTIVES: I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy. SECONDARY OBJECTIVES: I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite \[EPIC\] and International Prostate Symptom Score \[IPSS\] questionnaires). II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue. III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT. OUTLINE: Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy. After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.
Investigators
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)
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
Outcomes
Primary Outcomes
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Time Frame: At 4 weeks post surgery
Secondary Outcomes
- Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.(score from baseline to twelve months)
- Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.(Mean change in I-PSS score from baseline to 12 months.)
- Correlative Biomarker Analyses Using Tissue and Serial Blood Samples(Baseline and to up to 1 year)
- Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities(Up to 1 year)