Trial Title:
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
NCT ID:
NCT05830838
Condition:
Malignant Prostate Neoplasm
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Group I (daily adaptive online replanning, SBRT)
Arm group label:
Group II (daily adaptive online replanning, SBRT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
Image-Guided Adaptive Radiation Therapy
Description:
Undergo daily adaptive online replanning for SBRT
Arm group label:
Group I (daily adaptive online replanning, SBRT)
Arm group label:
Group II (daily adaptive online replanning, SBRT)
Other name:
IGART
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Group I (daily adaptive online replanning, SBRT)
Arm group label:
Group II (daily adaptive online replanning, SBRT)
Other name:
Magnetic Resonance
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:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Group I (daily adaptive online replanning, SBRT)
Arm group label:
Group II (daily adaptive online replanning, SBRT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Group I (daily adaptive online replanning, SBRT)
Arm group label:
Group II (daily adaptive online replanning, SBRT)
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo SBRT
Arm group label:
Group I (daily adaptive online replanning, SBRT)
Arm group label:
Group II (daily adaptive online replanning, SBRT)
Other name:
SABR
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
Summary:
This clinical trial evaluates the feasibility, safety, and tolerability of stereotactic
ablative radiotherapy (SABR) using daily adaptive radiation techniques to the prostate
fossa and/or pelvic lymph nodes in patients with prostate cancer who have undergone
surgical removal of the prostate (radical prostatectomy). For patients with prostate
cancer who develop a rising prostate specific antigen (PSA) after radical prostatectomy,
salvage radiation therapy is the standard of care treatment. Radiation therapy uses high
energy x-rays to kill tumor cells and shrink tumors. All patients receiving salvage
radiation following radical prostatectomy typically have treatment directed to the
prostate fossa, which is the anatomical region around the operative bed that is at
highest risk for containing left over tumor. Many patients receiving salvage radiation
therapy can also benefit from treatment of the pelvic lymph nodes. Adaptive radiotherapy
is an emerging treatment technique that uses daily imaging to adjust treatment volumes,
ensure accurate dose delivery, and allow the use of smaller planning target volume
margins. Adaptive radiation is ideally suited for the further implementation of SABR
treatment regimens directed to the prostate fossa with or without inclusion of the pelvic
lymph nodes. While daily adaptive radiation therapy has been reported in other disease
settings, there is currently no data about its use for post-prostatectomy radiation.
Using daily adaptive radiation techniques may help researchers learn how to minimize
exposure to normal tissue and shorten the number of required treatments to better target
the radiation dose in prostate cancer patients post-prostatectomy.
Detailed description:
PRIMARY OBJECTIVE:
I. To demonstrate the safety of daily, adaptive online replanning in patients treated
with stereotactic body radiation therapy (SBRT) to the prostate +/- pelvic lymph nodes as
defined by observation of a grade 3 genitourinary and gastrointestinal toxicity rate of
less than or equal to 5%.
SECONDARY OBJECTIVES:
I. To determine the feasibility of daily, adaptive online replanning for patients
receiving SBRT to the prostate fossa +/- pelvic lymph nodes.
II. To assess the efficacy of daily, adaptive SBRT to the prostate fossa. III. To measure
the change in patient reported urinary, bowel, and sexual outcomes following protocol
treatment.
EXPLORATORY OBJECTIVE:
I. To assess the dosimetric benefits of daily adaptive replanning for prostate
fossa/pelvic lymph node SBRT.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients undergo daily adaptive online replanning for SBRT to the prostate fossa
on study. Patients also undergo (MRI) of the prostate fossa and pelvis and may undergo
positron emission tomography/computed tomography (PET/CT) during screening.
GROUP II: Patients undergo daily adaptive online replanning for SBRT to the prostate
fossa and pelvic lymph nodes on study. Patients also undergo MRI of the prostate fossa
and pelvis and may undergo PET/CT during screening.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Males age >= 18 years who are receiving post-operative radiation therapy to the
prostate fossa, with or without inclusion of the pelvic lymph nodes, for biochemical
recurrences after radical prostatectomy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =< 2.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide written informed consent.
- Willingness and ability to complete protocol-specified follow-up (during the active
monitoring phase of the study).
Exclusion Criteria:
- Current evidence of untreated metastatic prostate cancer involving nonregional lymph
nodes outside of the bony pelvis, bone, or visceral organs.
- Receipt of cytotoxic chemotherapy within 3 months prior to enrollment.
- Prior radiation therapy to pelvis such that the proposed study treatment volume
received 10 Gy or greater.
- Co-morbid severe concurrent disease that would result in a life expectancy of < 5
years.
- Diabetes mellitus-associated vascular ulcers or wounding healing problems,
inflammatory bowel disease, or a diagnosed connective tissue disorder.
- Medical or psychiatric conditions that preclude informed decision-making or
adherence to study protocols.
- Men of childbearing potential who are unwilling to employ adequate contraception.
- History of a bladder neck contracture, urethral stricture that required dilation, or
any surgical repair/reconstruction involving the bladder or urethra other than
radical prostatectomy.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Start date:
July 28, 2023
Completion date:
May 30, 2029
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/NCT05830838
https://www.mayo.edu/research/clinical-trials
