Stage I Prostate AdenocarcinomaNCT02470897
Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer
A study testing Radiation Therapy Treatment Planning and Simulation and SBRT in people with Stage I Prostate Adenocarcinoma and Stage II Prostate Adenocarcinoma, run by University of Wisconsin, Madison at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Stage I Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma
- What is being tested?
- Radiation Therapy Treatment Planning and Simulation and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jul 2015to 18 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UW Cancer Center, Johnson Creek
Johnson Creek, Wisconsin, 53038
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Swedish American
Rockford, Illinois, 61104
About this study
Official title: A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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: Participants are assigned to 1 of 2 treatment arms. Participants 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: (n = 120) Participants 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: (n = 40) Participants 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 4-8 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.
Per protocol amendment in December 2023, the follow up time period for data collection will change to 3 years after the last participant completed treatment.
- Being tested
- Radiation Therapy Treatment Planning and Simulation, SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Therapy Treatment Planning and SimulationRadiation
Also called Radiation Therapy Treatment Planning/Simulation
Undergo urethral-sparing IMRT planning
SBRTRadiation
Also called Stereotactic Body Radiation Therapy
Undergo moderate dose SBRT with SIB
SBRTRadiation
Also called Stereotactic Body Radiation Therapy
Undergo uniform dose SBRT
| Study group | Role | What they receive |
|---|---|---|
| Arm A (moderate dose SBRT with SIB) | Experimental | Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning.
SBRT: 8.0Gy escalated dose Receives: Radiation: Radiation Therapy Treatment Planning and Simulation; Radiation: SBRT |
| Arm B (uniform dose SBRT) | Active comparator | Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning.
SBRT: 7.5Gy conventional dose Receives: Radiation: Radiation Therapy Treatment Planning and Simulation; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Gastrointestinal (GI) Acute Toxicity
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 (SIB - Arm A). Acute Toxicity is defined as occurring on-treatment or within 6 weeks.
Measured: during treatment (days 1 to 5), 6 week follow up
Number of Participants Experiencing Genitourinary (GU) Acute Toxicity
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for added grade 3 rectal toxicity with the use of a simultaneous integrated boost (SIB - Arm A). Acute toxicities were defined as occurring on-treatment or within 6 weeks.
Measured: during treatment (days 1 to 5), 6 week follow up
Number of Participants Experiencing GI Late Toxicity
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 (Arm A). A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of radiation therapy (RT).
Measured: Every 6 months up to 6 years
Number of Participants Experiencing GU Late Toxicity
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 (Arm A). A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of RT.
Measured: Every 6 months up to 6 years
Disease-free Survival as Measured by the Phoenix Definition
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. Participants will be considered to be without biochemical recurrence if either the PSA is still declining or the prostate-specific antigen (PSA) has not risen above its nadir by ≥ 2 ng/ml (Phoenix definition).
Measured: Up to 5 years
Secondary outcomes (7)
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Urinary Incontinence Sub-Domain
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Measured: at Baseline, 1 year, and 2 years
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Urinary Irritative / Obstructive Sub-Domain
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Measured: at Baseline, 1 year, and 2 years
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Bowel Sub-Domain
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Measured: at Baseline, 1 year, and 2 years
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Sexual Sub-Domain
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Measured: at Baseline, 1 year, and 2 years
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Hormonal Sub-Domain
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Measured: at Baseline, 1 year, and 2 years
Change in American Urological Association Symptom Score (AUASS)
The AUASS has a total possible range of scores of 0-35 where 1-7 is considered mild symptoms, 8-19 is considered moderate symptoms, and 20-35 is considered severe symptoms. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Measured: at Baseline, 1 year, and 2 years
Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)
The IIEF-5 questionnaire has a total score of 1-25 where 1-7 is considered severe erectile dysfunction (ED), 8-11 is moderate ED, 12-16 is mild-moderate ED, 17-21 is mild ED, and 22-25 is no ED. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Measured: at Baseline, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start24 Jul 2015
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage I Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zachary Morris, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470897
- Sponsor's protocol ID
- 2015-0395
- Other IDs
- NCI-2015-00950, 2015-0395, UW14083, A533300, SMPH\HUMAN ONCOLOGY\HUMAN ONCO, Protocol Version 11/8/2023
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2015
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Morris BA, Holmes EE, Anger NJ, Cooley G, Schuster JM, Hurst N, Baschnagel AM, Bassetti MF, Blitzer GC, Chappell RJ, Bayliss RA, Morris ZS, Ritter MA, Floberg JM. Toxicity and Patient-Reported Quality-of-Life Outcomes After Prostate Stereotactic Body Radiation Therapy With Focal Boost to Magnetic Resonance Imaging-Identified Prostate Cancer Lesions: Results of a Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):613-623. doi: 10.1016/j.ijrobp.2023.05.004. Epub 2023 May 12.
PubMed 37179035