Trial Title:
Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
NCT ID:
NCT06325046
Condition:
Localized Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC V8
Stage II Prostate Cancer AJCC V8
Stage III Prostate Cancer AJCC V8
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Arm I (near margin-less ART)
Arm group label:
Arm II (standard SABR)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Cone-Beam Computed Tomography
Description:
Undergo CBCT
Arm group label:
Arm I (near margin-less ART)
Other name:
Cone Beam Computed Tomography
Other name:
Cone Beam CT
Intervention type:
Radiation
Intervention name:
Image-Guided Adaptive Radiation Therapy
Description:
Undergo near margin-less ART
Arm group label:
Arm I (near margin-less ART)
Other name:
IGART
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm I (near margin-less ART)
Arm group label:
Arm II (standard SABR)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Stereotactic Ablative Radiotherapy
Description:
Undergo standard SABR
Arm group label:
Arm II (standard SABR)
Other name:
SABER
Other name:
SABR
Other name:
SABR/SBRT
Other name:
Stereotactic Body Radiation Therapy (SBRT)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (near margin-less ART)
Arm group label:
Arm II (standard SABR)
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Gender assigned male at birth: age ≥ 18 years
- Histological confirmation of prostate adenocarcinoma
- National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low-
to intermediate-risk prostate adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to complete questionnaire(s) by themselves or with assistance
- Signed informed consent
- Willing to complete requirements for follow-up (during active monitoring phase)
Exclusion Criteria:
- NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate
adenocarcinoma
- Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy,
cryotherapy, or high intensity focused ultrasound (HIFU)
- Prior bladder outlet obstruction procedures including transurethral resection of the
prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral
vaporesection of the prostate (TUVRP), etc.
- Metastatic disease by conventional or molecular imaging
- Contraindications to radiation therapy (RT) including uncontrolled inflammatory
bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
- Concurrent antineoplastic agents (chemotherapy)
- Previous or concurrent malignancy other than non-melanoma skin cancer, indolent
lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5
years
- Medical or psychiatric conditions that preclude informed decision-making or
adherence with the protocol-defined treatment or follow-up
- Prostate gland volume > 80 cc based on magnetic resonance imaging (MRI), and/or
International Prostate Symptom Score (IPSS) composite score > 17
- Body weight > 200 kilogram
- Known allergy or sensitivity to polyethylene glycol (PEG) or iodine
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Health System in Albert Lea
Address:
City:
Albert Lea
Zip:
56007
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
John Yeakel, MD
Facility:
Name:
Mayo Clinic Health System-Mankato
Address:
City:
Mankato
Zip:
56001
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Lydia W. Ng, MD
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Mark R. Waddle, M.D.
Facility:
Name:
Mayo Clinic Health System-Eau Claire
Address:
City:
Eau Claire
Zip:
54701
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Now Bahar Alam, MD
Facility:
Name:
Mayo Clinic Health System-Franciscan Healthcare
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Abigail L. Stockham, MD
Start date:
August 15, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06325046
https://www.mayo.edu/research/clinical-trials
