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Prostate CancerPhase 2MIDASNCT07644598

MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer

A Phase 2 study testing Microboost SBRT, Whole gland de-escalation 30 Gy and Whole gland de-escalation 35 Gy in people with Prostate Cancer and Localized Prostate Carcinoma, run by Georgetown University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate 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 Cancer, Localized Prostate Carcinoma
What is being tested?
Microboost SBRT, Whole gland de-escalation 30 Gy and Whole gland de-escalation 35 Gy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
Sep 2026to Jan 2035
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Patients age 18 or older.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Patients with histologically confirmed adenocarcinoma of the prostate who have not received prior pelvic radiation therapy or prostatectomy.
  • Patients with low to intermediate risk group defined by the NCCN (National Comprehensive Cancer Network) guidelines as follows:
  • Low risk prostate cancer:
  • cT1-cT2a (AJCC; 8TH edition, 2017)
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  • Grade Group 1 (GG1)
  • PSA <10 ng/mL
  • Intermediate risk prostate cancer:
  • cT2b-cT2c (AJCC; 8TH edition, 2017)
  • Grade Group 2 (GG2) or Grade Group 3 (GG3)
  • PSA 10-20 ng/mL
  • Patients with unfavorable intermediate risk prostate cancer defined by the NCCN guidelines are recommended to undergo a PSMA (Prostate-Specific Membrane Antigen) PET, then the PSMA PET must show localized disease.
  • Patients must have preferably undergone a standard of care pretreatment MRI fusion biopsy* to identify visible intraprostatic lesions and confirm the absence of regional or distant metastatic disease, with criteria as follows:
  • Ability to undergo an MRI fusion biopsy;
  • Prostate size <100 cc on any diagnostic MRI;
  • Presence of a visible prostatic lesion:
  • PIRADS (Prostate Imaging-Reporting and Data System) 4+ lesion, and/or
  • PIRADS 3 lesion with evidence of grade group 2-3
  • Less than or equal to 4 lesions in total allowed;
  • Lesion may contact the capsular edge, "possible" extracapsular extension (ECE) permitted; *MRI fusion biopsy is preferred but if the positive core is in the same region as the target on the MRI based on a systemic biopsy, the patient can be included.
  • Genitourinary function with a baseline score ≤20 as defined by any pre-treatment IPSS questionnaire.
  • Patients are mandated to get a fiducial placement. Optional proper rectal spacer placement is recommended as determined by the treating radiation oncologist based upon whether there is overt rectal wall invasion from the hydrogel spacer or if there is minimal to no separation of the prostate-rectal interface measured at the prostate mid-gland.
  • Patients with a life expectancy of greater than 5 years as assessment by the investigator. Life expectancy can be estimated using any 1 of the following tools:
  • The Social Security Administration tables: https://www.ssa.gov/OACT/STATS/table4c6.html
  • The WHO's Life Tables by country: https://apps.who.int/gho/data/view.main.60000?lang=en
  • The Memorial Sloan Kettering Male Life Expectancy tool: https://www.mskcc.org/nomograms/prostate
  • If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.
  • Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:
  • With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method, which together result in a failure rate of < 1% per year, during the treatment period and for 1 year after treatment per local and institutional guidelines. Men must refrain from donating sperm during this same period.
  • With a pregnant female partner, men must remain abstinent or use a condom during the treatment period per local and institutional guidelines to avoid potential exposure to the embryo.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.
  • Patients who are able to give informed consent.

Who cannot join

  • Patients with evidence of disease Grade Group 4 (GG4) or higher.
  • Patients with PSA >20 ng/mL.
  • Patients with evidence of clinical stage T3a+ or gross extracapsular extension on the diagnostic MRI.
  • Patients who received prior or concurrent androgen deprivation therapy for prostate cancer.
  • Patients with more than 4 disease foci identifiable on MRI.
  • Patients with evidence of metastatic disease on imaging (e.g., bone scan, PSMA PET scan, or MRI/CT scan).
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  • Patients with ineligibility to undergo an MRI due to:
  • The presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MRI unsafe;
  • Severe claustrophobia;
  • Inability to lie flat for the duration of the study;
  • Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MRI;
  • Any other reason as determined by the investigator or treating physician.
  • Patients with an I-PSS score >20 as defined by any pre-treatment IPSS questionnaire.
  • Patients with a prior history of transurethral resection of the prostate, TURP, Urolift, or other similar trans-urethral LUTS management procedure within the last 6 months.
  • Patients with a prior history of severe urethral stricture.
  • Patients with a prior history of pelvic irradiation.
  • Patients unable to meet dosimetric constraints
  • Patients with a prior history of non-cutaneous solid malignancy within the last 5 years.
  • Patients with a history of active and uncontrolled inflammatory bowel disease.
  • Patients who are unable to comply with follow-up visits and treatment plans.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jonathan Lischalk, MD contact

2026879194

jonathan.w.lischalk@gunet.georgetown.edu

United States1 site, 1 recruiting

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

    Alan Zwart, (202) 687-0344, az6@georgetown.edu

    Jonathan Lischalk, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Study of MRI-based Focal Intraprostatic SIB (Simultaneous Integrated Boost) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer

The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective in managing patients with low to intermediate-risk prostate cancer while maintaining acceptable toxicity levels? All patients will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions. Patients (Arm 1) with highest grade disease in the microboost target lesion in the absence of GG2-3 beyond the microboost target (only GG1 disease can be present outside of the microboost region) will receive whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions. Patients (Arm 2) with highest grade disease outside of the target lesion will receive whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions. Participants will be treated every other day over a two week period and then follow up after radiation treament for up to 5 years. Participants will be asked to complete questionnaires and provide blood and urine samples for research purposes.

Being tested
Microboost SBRT, Whole gland de-escalation 30 Gy, Whole gland de-escalation 35 Gy
Keywords
Localized prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microboost SBRTRadiation

    Microboost SBRT at a dose of 45 Gy for 5 fractions

  • Whole gland de-escalation 30 GyRadiation

    Whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions.

  • Whole gland de-escalation 35 GyRadiation

    Whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions

Study groups in NCT07644598
Study groupRoleWhat they receive
Arm 1- Low RiskExperimentalPatients enrolled to arm 1 will have low risk prostate cancer without Grade Group 2-3 (GG2-3) outside of the microboost target(s). Patients in arm 1 will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions plus whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions.
Receives: Radiation: Microboost SBRT; Radiation: Whole gland de-escalation 30 Gy
Arm 2- Intermidiate RiskExperimentalPatients enrolled to arm 2 will have intermidiate risk prostate cancer with grade group 2-3 disease outside of the microboost target(s). Patients in arm 2 will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions plus whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions.
Receives: Radiation: Microboost SBRT; Radiation: Whole gland de-escalation 35 Gy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute grade 2 or higher genitourinary toxicity

    Safety of the microboost technique will be determined based on the incidence of acute grade 2 or higher genitourinary adverse events (AEs). AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used.

    Measured: during treatment through 90 days after radiation treatment

Secondary outcomes (11)

  1. Incidence of acute grade 2 or higher gastrointestinal (GI) toxicity

    The incidence of acute grade 2 or higher gastrointestinal AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used.

    Measured: Up to 5 years

  2. Incidence of late grade 2 or higher genitourinary (GU) or gastrointestinal (GI) toxicity

    The incidence of late grade 2 or higher genitourinary or gastrointestinal AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used.

    Measured: Up to 5 years

  3. Incidence of late grade 3 or higher genitourinary or gastrointestinal toxicity

    The cumulative incidence of late grade 3 or higher genitourinary or gastrointestinal AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used

    Measured: Up to 5 years

  4. PSA (Prostate-specific antigen) nadir

    PSA nadir is defined as the lowest PSA achieved at the time of follow up as determined by the treating physician. The PSA nadir will be determined by denoting the lowest value by 2- and 5-years of follow up.

    Measured: at 2 years and 5 years

  5. Biochemical failure (BF)

    Biochemical failure is defined as a PSA rise of at least 2.0 n/g/mL above the patient's PSA nadir following radiation treatment by the Phoenix definition and as determined by the treating physician.

    Measured: at 2 years and 5 years

  6. Biochemical failure free survival (BFFS)

    Biochemical failure free survival (BFFS) is defined as the length of time from radiation completion to the first documented evidence of biochemical failure of prostate cancer or death, whichever occurs first. Patients who are alive and free from biochemical failure will be censored at the date of last follow-up for BFFS.

    Measured: up to 5 years

  7. Disease-free survival (DFS)

    Defined as the length of time from radiation completion to the first evidence of biochemical or clinical recurrence of prostate cancer or death, whichever occurs first. Patients who are alive and free from disease recurrence will be censored at the date of last follow-up for DFS.

    Measured: up to 5 years

  8. Patient-reported QoL (Quality of life) outcomes- Expanded Prostate Index Composite (EPIC)-26

    Patient-reported QoL as measured by EPIC-26 questionnaire which measures health related quality of life. Scores range from 0 to 100 with higher scores indicating a better quality of life.

    The EPIC-26 instrument includes sub-scales like urinary function, bowel habits, and sexual function, which will be used to measure the changes in the GU (Genitourinary), GI (gastrointestinal), and sexual domains, respectively.

    Measured: up to 5 years

  9. Patient-reported QoL outcomes- International Prostate Symptom Score (I-PSS)

    The I-PSS is based on the answers to 7 questions concerning Urinary symptoms. Scores range from 0 to 35, with 0 being asymptomatic to 35 being very symptomatic.

    Measured: up to 5 years

  10. Patient-reported QoL outcomes- International Index of Erectile Dysfunction (IIEF-5)

    The IIEF-5 is a 5 question questionnaire which evaluates erectile dysfunction. Scores range from 5 to 25, 5-7 being severe erectile dysfunction and 22-25 being no erectile dysfunction.

    Measured: up to 5 years

  11. Patient-reported QoL outcomes- Health Questionnaire (EQ-5D-5L)

    EQ-5D-5L questionnaire will have participants evaluate their quality of life across 5 Dimensions including Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Index scores range from -0.59 to 1, where 1 is the best possible health state.

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2035 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07644598
Sponsor's protocol ID
STUDY00009733
Acronym
MIDAS
Status last verified
Jul 2026
First submitted
28 May 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Microboost SBRT, Whole gland de-escalation 30 Gy and Whole gland de-escalation 35 Gy in people with Prostate Cancer and Localized Prostate Carcinoma, run by Georgetown 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 33 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathan Lischalk, MD (2026879194, jonathan.w.lischalk@gunet.georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute grade 2 or higher genitourinary toxicity (time frame: during treatment through 90 days after radiation treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07644598.

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 20 Aug 2026.

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