Prostate AdenocarcinomaPhase 2NCT05676463
MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
A Phase 2 study testing MRI-guided Intensity-Modulated Radiation Therapy, Antiandrogen Therapy and PSMA PET Scan in people with Prostate Adenocarcinoma and Stage IIIB Prostate Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- What is being tested?
- MRI-guided Intensity-Modulated Radiation Therapy, Antiandrogen Therapy and PSMA PET Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 24 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate late grade 2+ genitourinary (GU) toxicity.
SECONDARY OBJECTIVE:
- 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
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Being tested
- MRI-guided Intensity-Modulated Radiation Therapy, Antiandrogen Therapy, PSMA PET Scan, Computed Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided Intensity-Modulated Radiation TherapyProcedure or surgery
Undergo MRI-guided IMRT
Antiandrogen TherapyDrug
Also called ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy
Receive SOC ADT
PSMA PET ScanProcedure or surgery
Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography
Undergo PSMA PET scan
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Undergo MRI
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo bone scan
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (MRI-guided IMRT, ADT) | Experimental | 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. Receives: Procedure: MRI-guided Intensity-Modulated Radiation Therapy; Drug: Antiandrogen Therapy; Procedure: PSMA PET Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Bone Scan; Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of late grade 2+ genitourinary (GU) toxicity
Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.
Measured: At 1 year
Secondary outcomes (24)
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: At baseline
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: At treatment completion, up to 10 days
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: every 3 months after treatment until 1 year
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: every 6 months beginning at year 2, assessed up to 4 years
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: At baseline
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: At treatment completion, up to 10 days
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: every 3 months after treatment until 1 year
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Measured: every 6 months beginning at year 2, assessed up to 4 years
Overall survival
Will be estimated using the Kaplan-Meier method.
Measured: At baseline
Overall survival
Will be estimated using the Kaplan-Meier method.
Measured: At treatment completion, up to 10 days
Overall survival
Will be estimated using the Kaplan-Meier method.
Measured: every 3 months after treatment until 1 year
Overall survival
Will be estimated using the Kaplan-Meier method.
Measured: every 6 months beginning at year 2, assessed up to 4 years
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Measured: At baseline
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Measured: At treatment completion, up to 10 days
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Measured: every 3 months after treatment until 1 year
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Measured: every 6 months beginning at year 2, assessed up to 4 years
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Measured: At baseline
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Measured: At treatment completion, up to 10 days
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Measured: every 3 months after treatment until 1 year
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Measured: every 6 months beginning at year 2, assessed up to 4 years
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Measured: At baseline
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Measured: At treatment completion, up to 10 days
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Measured: every 3 months after treatment until 1 year
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Measured: every 6 months beginning at year 2, assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start16 Nov 2022
- Primary completion7 Aug 2025
- Study completion24 Oct 2025
Why it stopped: Loss of required MRI resources needed to conduct protocol-specified procedures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessie DiNome, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676463
- Sponsor's protocol ID
- 22D.687
- Other IDs
- JT 20770
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2022
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)
- ClinicalTrials.gov ID
- NCT05676463
- Acronym / sponsor ID
- 22D.687
- Conditions
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of required MRI resources needed to conduct protocol-specified procedures
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate late grade 2+ genitourinary (GU) toxicity.
SECONDARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (MRI-guided IMRT, ADT) | Experimental | Procedure: MRI-guided Intensity-Modulated Radiation Therapy, Drug: Antiandrogen Therapy, Procedure: PSMA PET Scan, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Bone Scan, Procedure: Biospecimen Collection, Other: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-guided Intensity-Modulated Radiation TherapyUndergo MRI-guided IMRT | Procedure or surgery | Treatment (MRI-guided IMRT, ADT) |
| Antiandrogen TherapyAlso: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen TherapyReceive SOC ADT | Drug | Treatment (MRI-guided IMRT, ADT) |
| PSMA PET ScanAlso: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomographyUndergo PSMA PET scan | Procedure or surgery | Treatment (MRI-guided IMRT, ADT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT | Procedure or surgery | Treatment (MRI-guided IMRT, ADT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceUndergo MRI | Procedure or surgery | Treatment (MRI-guided IMRT, ADT) |
| Bone ScanAlso: Bone ScintigraphyUndergo bone scan | Procedure or surgery | Treatment (MRI-guided IMRT, ADT) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (MRI-guided IMRT, ADT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (MRI-guided IMRT, ADT) |
Primary outcome
Rate of late grade 2+ genitourinary (GU) toxicity
Time frame: At 1 year
Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.
24 secondary outcomes
Incidence of acute GU and gastrointestinal (GI) toxicity
Time frame: At baseline
Incidence of acute GU and gastrointestinal (GI) toxicity
Time frame: At treatment completion, up to 10 days
Incidence of acute GU and gastrointestinal (GI) toxicity
Time frame: every 3 months after treatment until 1 year
Incidence of acute GU and gastrointestinal (GI) toxicity
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Incidence of late GI toxicity
Time frame: At baseline
Incidence of late GI toxicity
Time frame: At treatment completion, up to 10 days
Incidence of late GI toxicity
Time frame: every 3 months after treatment until 1 year
Incidence of late GI toxicity
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Overall survival
Time frame: At baseline
Overall survival
Time frame: At treatment completion, up to 10 days
Overall survival
Time frame: every 3 months after treatment until 1 year
Overall survival
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Prostate cancer specific survival
Time frame: At baseline
Prostate cancer specific survival
Time frame: At treatment completion, up to 10 days
Prostate cancer specific survival
Time frame: every 3 months after treatment until 1 year
Prostate cancer specific survival
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Biochemical failure
Time frame: At baseline
Biochemical failure
Time frame: At treatment completion, up to 10 days
Biochemical failure
Time frame: every 3 months after treatment until 1 year
Biochemical failure
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Quality of life measurement
Time frame: At baseline
Quality of life measurement
Time frame: At treatment completion, up to 10 days
Quality of life measurement
Time frame: every 3 months after treatment until 1 year
Quality of life measurement
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Results and safety
The study was stopped early (reason given: Loss of required MRI resources needed to conduct protocol-specified procedures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessie DiNome, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRI-guided Intensity-Modulated Radiation Therapy, Antiandrogen Therapy and PSMA PET Scan in people with Prostate Adenocarcinoma and Stage IIIB Prostate Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Loss of required MRI resources needed to conduct protocol-specified procedures). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of late grade 2+ genitourinary (GU) toxicity (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.