A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 115
- Locations
- 6
- Primary Endpoint
- Incidence of GU and GI Acute Toxicity
Study Overview
Brief Summary
This phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the incidence of genitourinary (GU) and gastrointestinal (GI) acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with simultaneous integrative boost, urethral ring sparing, and enhanced prostate localization (magnetic resonance imaging [MRI\-computed tomography [CT] fusion).
II. To also evaluate the incidence of GU and GI acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with a more conventional and uniformly delivered dose of 7.25 Gy/fraction to the prostate.
III. Disease-free survival: disease-free failure events include local progression, distant progression, biochemical failure as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, and death from any cause.
SECONDARY OBJECTIVES:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate and most recent biopsy within 180 days of study enrollment
- •History/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollment
- •Gleason score =< 7, no tertiary pattern >= 5
- •Clinical stage =< T2b (American Joint Committee on Cancer [AJCC] 7th Edition Staging Manual) and no radiographic evidence of T3 or T4 disease
- •Clinical stage N0, M0
- •Most recent prostate specific antigen (PSA) within 60 days of enrollment
- •Maximum PSA =< 20 ng/ml (not within 20 days after biopsy)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •American Urological Association (AUA) =< 18 with or without medical management
- •Up to a total of year of androgen deprivation allowed.
- •Participant signs study specific informed consent prior to study enrollment
Exclusion Criteria
- •FOR ARM A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan
- •FOR BOTH ARM A AND ARM B:
- •Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years; (for example, carcinoma in situ of the bladder or oral cavity is permissible)
- •Prosthetic implants in the pelvic region that the investigator feels will impede treatment, planning, or delivery (e.g., an artificial hip)
- •=< 3 months from a transurethral resection of the prostate (TURP) procedure
- •Significant urinary obstruction (i.e. AUA symptom score > 18)
- •Previous pelvic irradiation, prostate brachytherapy
- •Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- •Severe, active comorbidity, defined as follows:
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Crohn's disease or ulcerative colitis
- •Scleroderma
Outcomes
Primary Outcomes
Incidence of GU and GI Acute Toxicity
Time Frame: Up to 90 days
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost.
Incidence of GU and GI Late Toxicity
Time Frame: Up to 3 years
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost. A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of RT.
Disease-free survival as measured by the Phoenix definition
Time Frame: Up to 3 years
Secondary Outcomes
- Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment(at Baseline, 1 year, and 2 years)
- Change in American Urological Association Symptom Score (AUASS)(at Baseline, 1 year, and 2 years)
- Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)(at Baseline, 1 year, and 2 years)