Trial Title:
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
NCT ID:
NCT06205316
Condition:
Biochemically Recurrent Prostate Carcinoma
Oligometastatic Prostate Carcinoma
Recurrent Prostate Adenocarcinoma
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
Adenocarcinoma
Recurrence
Ascorbic Acid
Methyltestosterone
Hormones
Estrogens, Conjugated (USP)
Androgens
Androgen Antagonists
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Antiandrogen Therapy
Description:
Receive ADT
Arm group label:
Group I (SBRT)
Arm group label:
Group II (Hypofractionated radiation therapy)
Other name:
ADT
Other name:
Androgen Deprivation Therapy
Other name:
Androgen Deprivation Therapy (ADT)
Other name:
Anti-androgen Therapy
Other name:
Anti-androgen Treatment
Other name:
Antiandrogen Treatment
Other name:
Hormone Deprivation Therapy
Other name:
Hormone-Deprivation Therapy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Group I (SBRT)
Arm group label:
Group II (Hypofractionated radiation therapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Group I (SBRT)
Arm group label:
Group II (Hypofractionated radiation therapy)
Other name:
Bone Scintigraphy
Intervention type:
Radiation
Intervention name:
Hypofractionated Radiation Therapy
Description:
Undergo hypofractionated radiation therapy
Arm group label:
Group II (Hypofractionated radiation therapy)
Other name:
Hypofractionated
Other name:
Hypofractionated Radiotherapy
Other name:
hypofractionation
Other name:
Radiation, Hypofractionated
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Group I (SBRT)
Arm group label:
Group II (Hypofractionated radiation therapy)
Other name:
Magnetic Resonance
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:
Positron Emission Tomography
Description:
Undergo PET scan
Arm group label:
Group I (SBRT)
Arm group label:
Group II (Hypofractionated radiation therapy)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo SBRT
Arm group label:
Group I (SBRT)
Other name:
SABR
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary study
Arm group label:
Group I (SBRT)
Arm group label:
Group II (Hypofractionated radiation therapy)
Summary:
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT)
compared to hypofractionated radiotherapy for treating patients with prostate
adenocarcinoma that has come back after a period of improvement (recurrent) or that has
spread from where it first started (primary site) to a limited number of sites
(oligometastatic). SBRT 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. Hypofractionated
radiation therapy delivers higher doses of radiation therapy over a shorter period of
time and may kill more tumors cells and have fewer side effects. SBRT may work just as
well as hypofractionated radiation therapy at treating patients with biochemically
recurrent or oligometastatic prostate cancer, but with a shorter treatment time and
possibly fewer side effects.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine if salvage SBRT is non-inferior to moderately hypofractionated radiation
therapy regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI)
grade 3 or higher within 2-years.
EXPLORATORY OBJECTIVES:
I. After completion of radiation therapy, determine the incidence of:
Ia. Disease free survival (DFS), defined as the first occurrence of new clinical failure
(local recurrence, regional recurrence, or distant metastasis) after salvage radiation
therapy (RT); Ib. Grade 2 or greater GU and GI toxicity at 3 years (Common Terminology
Criteria for Adverse Events [CTCAE] version 4); Ic. Grade 3 or greater GU and GI toxicity
at 3 years (CTCAE version 4); Id. Quality of life following completion of radiation
therapy; Ie. Impotence after the use of radiation therapy at 3 years; If. Freedom from
biochemical failure (FFBF) at 5 years; Ig. Local failure at 5 years; Ih. Regional failure
at 5 years; Ii. Distant failure at 5 years; Ij. Salvage androgen deprivation therapy
(ADT) use (SAD) at 5 years; Ik. Progression free survival: using clinical, biochemical
and SAD as events at 5 years; Il. Overall survival at 5 years; Im. Disease-specific
survival at 5 years. II. Determine the impact of salvage SBRT and hypofractionated
radiation therapy (HFRT) on quality of life.
III. Determine prostate and normal structure movement during RT with the use of scans.
IV. Correlate pathologic and radiologic findings with outcomes. V. Correlate pre-RT
prostate specific antigen (PSA) levels with outcomes. VI. Prospectively collect
information that will help to define dose-volume relationships of normal structures with
acute and chronic toxicity.
VII. Allow for future research of pathologic risk factors that may influence prognosis;
this information will help us to attempt to characterize their presence in prostate
cancer with high-risk features after prostatectomy and their potential effect on
outcomes.
VIII. Prospectively record contours that were manually drawn versus (vs.) edited from
artificial intelligence (AI)-generated contours.
IX. Determine the impact of using artificial intelligence (AI) tools for automatic
segmenting prostate bed and other organs at risk, in terms of toxicities and outcome.
X. Determine if there are any significant differences in dose-volumes results for cases
that involved AI-autosegmentation vs. cases without.
XI. Determine the relationship between the use of AI-autosegmentation tools with
toxicities and outcome.
XII. Different online daily imaging guidance systems are allowed in this trial, including
x-rays, conventional Feldkamp-Davis-Kress (FDK)-based cone beam computed tomography
(CBCT), and iterative CBCT. Subgroup analysis will be performed to determine patient
alignment accuracy and toxicities rates with respect to different online daily imaging
systems.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo SBRT over 15-20 minutes every other day for a total of 5
treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity.
Patients may receive androgen deprivation therapy for up to 18 months, as clinically
indicated. Patients undergo bone scan and positron emission tomography (PET) at screening
and treatment failure, and undergo magnetic resonance imaging (MRI) and blood sample
collection throughout the study.
GROUP II: Patients undergo hypofractionated radiation therapy over 15-20 minutes once per
day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or
unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18
months, as clinically indicated. Patients undergo bone scan and PET at screening and
treatment failure, and undergo MRI and blood sample collection throughout the study.
After completion of study treatment, patients follow up at 3 months, 12 months, annually
until year 5 and then every other year until death.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report
(American Joint Committee on Cancer [AJCC] Criteria 8th edition [Ed.])
- PSA post radical prostatectomy ≥ 0.1 and < 2.0 ng/mL ≤ 90 days prior to enrollment,
obtained ≥ 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤
90 days of enrollment
- Patients must sign institutional review board (IRB) approved study specific informed
consent
- Patients must complete all required pre-entry tests within the specified time frames
- Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study
registration
- Patients must be ≥ 18 years old
- Prostate cancer up to oligometastatic disease, up to 5 sites
Exclusion Criteria:
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative
colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are
allowed)
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
- Major medical, addictive, or psychiatric illness which in the investigator's
opinion, will prevent the consent process, completion of the treatment and/or
interfere with follow-up. (Consent by legal authorized representative is not
permitted for this study)
- History of myocardial infarction or decompensated congestive heart failure (CHF)
within the last 6 months
- On a transplant list
- More than oligometastatic disease > 5 metastatic sites
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Carlos E. Vargas, M.D.
Email:
Principal Investigator
Start date:
January 22, 2024
Completion date:
January 22, 2030
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/NCT06205316
https://www.mayo.edu/research/clinical-trials
