Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer
Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma
Intervention: Radiation Therapy Treatment Planning and Simulation (Radiation); Stereotactic Body Radiation Therapy (Radiation); Stereotactic Body Radiation Therapy (Radiation)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s): Mark Ritter, Principal Investigator, Affiliation: University of Wisconsin Hospital and Clinics
Overall contact: Cancer Connect, Phone: (800) 622-8922, Email: cancerconnect@uwcarbone.wisc.edu
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.
Clinical Details
Official title: A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Biochemical disease-free survival as measured by the Phoenix definitionBiochemical disease-free survival as measured by the Phoenix definition Cause-specific survival Disease-free survival Incidence of acute (=< 90 days) GI toxicities, scored according to the modified Fox Chase Late Effects Normal Tissue (FC-LENT) criteria Incidence of acute (=< 90 days) GU toxicities, scored according to the modified RTOG criteria Incidence of early adverse events, defined as an adverse event occurring less than or equal to 90 days from completion of RT, scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.0 (general, unexpected) criteria Incidence of late (> 90 days) GI toxicities, scored according to the modified FC-LENT criteria Incidence of late (> 90 days) GU toxicities, scored according to the modified RTOG criteria Metastasis-free survival Time to late adverse events, defined as an adverse event occurring more than 90 days from the completion of RT, scored according to the CTCAE v.4.0 (general, unexpected) criteria
Secondary outcome: Erectile function, assessed using the International Index of Erectile Function QuestionnaireOverall QOL, assessed using EPIC 26 quality of life assessment Urinary QOL, assessed with the AUA Symptom Score (SS) questionnaire
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:
I. Evaluate patient quality of life (QOL) using the Expanded Prostate Cancer Index Composite
26 (EPIC-26) for evaluation of the QOL for up to 3 years after the completion of SBRT.
OUTLINE: Patients are assigned to 1 of 2 treatment arms. Patients unable to undergo MRI,
whose MRI proves technically inadequate for delineating needed anatomic structures, or who
decline to enroll on Arm A are assigned to Arm B.
ARM A: Patients undergo 5 fractions of moderate dose SBRT with simultaneous integrated boost
(SIB) every other day for 10 days following urethral-sparing IMRT planning.
ARM B: Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days
following undergo urethral-sparing IMRT planning.
After completion of study treatment, patients are followed up at 4-6 weeks, at 4, 8, and 12
months, every 4 months for 1 year, every 6 months for 3 years, and then every 12 months
thereafter.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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 with no primary pattern >= 4, 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
- Patient signs study specific informed consent prior to study enrollment
- Confirmation that insurance will cover SBRT through normal hospital authorization
process
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 contain metal materials (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
Locations and Contacts
Cancer Connect, Phone: (800) 622-8922, Email: cancerconnect@uwcarbone.wisc.edu
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin 53792, United States; Recruiting Cancer Connect, Phone: 800-622-8922, Email: cancerconnect@uwcarbone.wisc.edu Mark A. Ritter, Principal Investigator
Additional Information
Starting date: July 2015
Last updated: July 29, 2015
|