NCT Number: NCT06325046
This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, United States
PRIMARY OBJECTIVE:
I. To evaluate treatment-related, patient-reported early quality of life (QOL) changes between near "margin-less" ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions, using the Expanded Prostate Cancer Index Composite (EPIC)-26 bowel and urinary irritative/obstructive domains.
SECONDARY OBJECTIVES:
I. To assess treatment-related, patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritative/obstructive domains.
II. To assess and compare early physician-reported grade ≥ 2 gastrointestinal (GI) and/or genitourinary (GU) toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
III. To assess and compare patient-reported financial toxicities, using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) assessment tool.
IV. To assess and compare late physician-reported grade ≥ 2 GI and/or GU toxicities of interest within 24 months after SABR using the CTCAE v5.0.
V. To assess and compare change in International Index of Erectile Function (IIEF-15) and International Prostate Symptom Score (IPSS).
VI. To explore the association of fiducial-free treatment on dosimetry, patient reported outcomes (PROs), and toxicity.
VII. To explore the association of bladder filling on dosimetry, PROs, and toxicity.
VIII. To assess and compare the cumulative incidence of biochemical failure, local progression, distant metastasis, and metastasis-free survival within 60 months after SABR.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo near margin-less adaptive radiation therapy (ART) for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo cone beam computed tomography (CBCT) and may undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study.
ARM II: Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
After completion of study treatment, patients are followed up at months 1, 3, and 6, and then every 6 months for up to 60 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo CT
Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Undergo CBCT
Other names: Cone Beam Computed Tomography, Cone Beam CT
Undergo near margin-less ART
Other names: IGART
Undergo MRI
Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo standard SABR
Other names: SABER, SABR, SABR/SBRT, Stereotactic Body Radiation Therapy (SBRT)
Ancillary studies
Time frame: Baseline; up to 3 months
Will be assessed using the Expanded Prostate Cancer Index Composite (EPIC)-26. The EPIC-26 consists of 13 questions answered on a variety of scales, such as 1-5 where 1=very poor and 5=very good.
Time frame: Baseline; up to 24 months
Will be assessed using the EPIC-26 questionnaire, as described above.
Time frame: Up to 24 months
Incidence of adverse events will be recorded at study visits. An adverse event is defined as any undesirable experience associated with the use of a medical product in a patient.
Time frame: Baseline; up to 24 months
The IIEF consists of 15 questions answered with various scales (e.g., a scale of 5-1 where 5=almost always or always and 1=almost never or never). Possible scores range from 5 to 25, and erectile dysfunction (ED) is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Time frame: Baseline; up to 24 months
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life.Each question is answered on a scale of 0-5 where 0=not at all/none and 5=almost always/5 5times.
Time frame: Baseline; 12 months
Change in financial adverse events will be assessed using the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) assessment tool. The COST-FACIT consists of 12 questions, each answered on a scale of 0-4 where 0=not al all and 4=very much.
Time frame: Up to 5 years
Will evaluate associations of fiducial-free treatment on dosimetry, patient reported outcomes (PROs), and toxicity. A fiducial is medical device or small object placed in or on the body to mark an area for radiation treatment or surgery. For example, tiny gold seeds may be put into the prostate to mark a tumor before radiation therapy.
Time frame: Up to 5 years
Will evaluate associations of bladder filling on dosimetry, patient reported outcomes (PROs), and toxicity using Fisher's exact test and the nonparametric Wilcoxon sum rank test.
Time frame: At 2 and 5 years
Biochemical disease recurrence will be estimated using the Kaplan-Meier method and compared using the log-rank test for each timepoint. Biochemical failure is defined as a prostate-specific antigen (PSA) value that is ≥ PSA nadir + 2.0 ng/mL with the date of biochemical failure set at the date of the PSA value that meets this criterion.
Time frame: Up to 5 years
Median PSA nadir as well as median time to nadir will be reported
Time frame: Up to 5 years
Local recurrence is defined as Magnetic Resonance Imaging (MRI) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/Computed Tomography (CT) evidence of recurrence disease in conjunction with biochemical failures.
Time frame: From the date of registration to the date of death from any cause, assessed up to 5 years
Survival duration will be measured from the date of registration to the date of death from any cause.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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