MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
NCT ID: NCT05676463
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
6 participants
INTERVENTIONAL
2022-11-16
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase I/II Hypofractionated Radiotherapy for Prostate Cancer
NCT00214097
High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
NCT02177292
Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
NCT00214136
A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer
NCT04190446
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
NCT00331773
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
MRI-guided Intensity-Modulated Radiation Therapy
Undergo MRI-guided IMRT
Antiandrogen Therapy
Receive SOC ADT
PSMA PET Scan
Undergo PSMA PET scan
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Bone Scan
Undergo bone scan
Biospecimen Collection
Undergo blood sample collection
Quality-of-Life Assessment
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI-guided Intensity-Modulated Radiation Therapy
Undergo MRI-guided IMRT
Antiandrogen Therapy
Receive SOC ADT
PSMA PET Scan
Undergo PSMA PET scan
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Bone Scan
Undergo bone scan
Biospecimen Collection
Undergo blood sample collection
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Thomas Jefferson University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jessie DiNome, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JT 20770
Identifier Type: OTHER
Identifier Source: secondary_id
22D.687
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.