Trial Title:
MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
NCT ID:
NCT05676463
Condition:
Prostate Adenocarcinoma
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Ascorbic Acid
Methyltestosterone
Hormones
Estrogens, Conjugated (USP)
Androgens
Androgen Antagonists
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Suspended
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
MRI-guided Intensity-Modulated Radiation Therapy
Description:
Undergo MRI-guided IMRT
Arm group label:
Treatment (MRI-guided IMRT, ADT)
Intervention type:
Drug
Intervention name:
Antiandrogen Therapy
Description:
Receive SOC ADT
Arm group label:
Treatment (MRI-guided IMRT, ADT)
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:
PSMA PET Scan
Description:
Undergo PSMA PET scan
Arm group label:
Treatment (MRI-guided IMRT, ADT)
Other name:
Prostate-specific Membrane Antigen PET
Other name:
PSMA PET
Other name:
PSMA-Positron emission tomography
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (MRI-guided IMRT, ADT)
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
Other name:
Computerized axial tomography (procedure)
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (MRI-guided IMRT, ADT)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging
Other name:
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
Other name:
Magnetic resonance imaging (procedure)
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Treatment (MRI-guided IMRT, ADT)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (MRI-guided IMRT, ADT)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Treatment (MRI-guided IMRT, ADT)
Other name:
Quality of Life Assessment
Summary:
This phase II trial tests whether magnetic resonance imaging (MRI)-guided
hypofractionated radiation therapy works to reduce treatment time and side effects in
patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy
delivers higher doses of radiation therapy over a shorter period of time directly to
diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on
areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared
to the longer standard of care therapy and may reduce the number and/or duration of side
effects.
Detailed description:
PRIMARY OBJECTIVE:
I. Evaluate late grade 2+ genitourinary (GU) toxicity.
SECONDARY OBJECTIVE:
I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall
survival, prostate cancer specific survival, biochemical failure, and quality of life.
OUTLINE:
Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and
receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients
may also undergo prostate specific membrane antigen (PSMA) positron emission tomography
(PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection
of blood samples throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years
and then every 6 months for a total of 4 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: above 18 years
- Participants must be histologically proven, adenocarcinoma prostate
- Localized to the prostate without positive pelvic lymph node involvement
- No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT
scan
- High risk prostate cancer as defined by National Comprehensive Cancer Network
(NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific
antigen (PSA) > 20 ng/mL
- Ability to receive long term hormone therapy
- Karnofsky performance score (KPS) > 70
- No prior history of therapeutic irradiation to pelvis
- Patient willing and reliable for follow-up and quality of life (QOL)
- English speaking/reading
Exclusion Criteria:
- Evidence of distant or pelvic metastasis at any time since presentation
- Life expectancy < 2 years
- Previous radiation therapy (RT) to prostate or prostatectomy
- A previous trans-urethral resection of the prostate (TURP)
- Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS)
score despite being on hormonal therapy for 6 months which in the opinion of the
physician precludes RT
- Patients with known obstructive symptoms with stricture
- Any contraindication to radiotherapy such as inflammatory bowel disease
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Start date:
November 16, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05676463
