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Prostate CancerPhase 2NCT07325721

Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

A Phase 2 study testing Hypofractionated radiation with a microboost in people with Prostate Cancer and Prostate Cancer Patients Treated by Radiotherapy, run by Medical University of South Carolina 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
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Trial summary

This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Hypofractionated radiation with a microboost
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
2 Feb 2026to 1 Jan 2034
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

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Biologically male patients aged 18 years and older.
  • Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen.
  • Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior transurethral resection of prostate (TURP) is permitted if 90 days or more prior to the start of radiotherapy.
  • Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following:
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  • PSA >20 ng/mL prior to starting ADT.
  • cT3a-T4 by digital exam or imaging.
  • Gleason score of 8-10 (grade group 4 or 5).
  • Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the aortic bifurcation) based on soft tissue imaging within 120 days prior to registration (may include CT, MRI or PSMA PET/CT, of fluciclovine choline PET/CT).
  • History and physical exam within 120 days prior to registration.
  • ECOG performance status 0-2.
  • Be able to undergo MRI of the prostate and/or pelvis as a component of RT planning.
  • Have at least one MRI visible target for microboost (PI-RADS≥ 4 version 2.0).
  • Bone and soft tissue imaging as clinically indicated for staging within 120 days prior to registration.
  • For males: use of condoms or other methods to ensure effective contraception with partner during radiation and for six months after completion of radiation.
  • Adequate hematologic function within 120 days prior to registration as defined by:
  • hemoglobin >=9.0 g/dL independent of transfusion, and
  • platelet count >= 100,000 x 10 ^9/microliter independent of transfusion.
  • Adequate hepatic function within 120 days prior to registration defined as total bilirubin <2 x institutional upper limits of normal (ULN is 1.2 mg/dL). If labs are done at outside institution, total bilirubin should be <2.4.
  • Agreeable and eligible to receive long term (defined as 12-36 months) ADT as a standard component of prostate cancer therapy.

Who cannot join

  • 1. Concurrent use of testosterone supplementation unless discontinued by time of registration.
  • 2. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes on conventional imaging (bone scan, CT scan, MRI).
  • 3. Prior pelvic radiotherapy. 4. Pre-existing conditions or overall health status which disqualifies the patient from curative intent-RT. Patients with life expectancy less than 5 years are not eligible.
  • 5. Treatment with another investigational prostate cancer therapy within 12 months.
  • 6. Prior total prostatectomy, cryotherapy, high-intensity focused ultrasound, irreversible electroporation, MRI ablation, laser ablation, transurethral ultrasound ablation, aquablation directed towards the prostate for any prostate disease or condition.
  • 7. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years.
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  • 8. Any condition that, in the opinion of the investigator, would preclude participation in this study.
  • 9. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 90 days prior to registration.
  • 10. Inability to undergo implantation of gold fiducial markers or rectal spacer gel.
  • 11. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

Trial locations and contacts

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

Harriet Eldredge-Hindy Eldredge-Hindy, MD contact

8437926382

eldredge@musc.edu

United States1 site, 1 recruiting

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina, 29425

    Casey Charlton, charltoc@musc.edu

    Recruiting

Other trials in United States

About this study

This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.

Being tested
Hypofractionated radiation with a microboost
Keywords
Prostate cancer, Microboost, hypofractionated
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Hypofractionated radiation with a microboostRadiation

    Patients will receive 25 fractions of external beam radiation therapy. Dose to the elective lymph nodes will be 45 Gy in 25 fractions. Dose to the prostate and portions of the seminal vesicles will be 68 Gy in 25 fractions. A microboost to up to three dominant intraprostatic nodules will be given in 25 fractions (dose range 70-83 Gy). Simultaneous integrated boost to sites of pelvic lymphadenopathy may be given. Androgen deprivation therapy will be per local standard of care.

Study groups in NCT07325721
Study groupRoleWhat they receive
Hypofractationed pelvic radiation with microboostExperimentalNot described
Receives: Radiation: Hypofractionated radiation with a microboost

What is being measured

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

  1. CTCAE grade 2 or higher acute genitourinary toxicity

    Measured: 1 month post radiation

Secondary outcomes (5)

  1. grade 2 or higher acute GI toxicity, late GU toxicity and late GI toxicity

    Measured: 5 years

  2. PSA failure rate

    Measured: 2 years

  3. death from any cause

    Measured: 5 years

  4. Mean change in Sexual Health Inventory for Men (SHIM) score

    Measured: 5 years

  5. Mean change in EPIC-26 sexual domain score from baseline

    Measured: 1 year

Timeline

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

  1. First posted8 Jan 2026
  2. Study start2 Feb 2026
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Jan 2034 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07325721
Sponsor's protocol ID
104214
Other IDs
Pro00147655
Status last verified
Feb 2026
First submitted
24 Nov 2025
Last updated
5 Feb 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 Hypofractionated radiation with a microboost in people with Prostate Cancer and Prostate Cancer Patients Treated by Radiotherapy, run by Medical University of South Carolina 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 21 inclusion and 10 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 5 Feb 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 Harriet Eldredge-Hindy Eldredge-Hindy, MD (8437926382, eldredge@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CTCAE grade 2 or higher acute genitourinary toxicity (time frame: 1 month post radiation). 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 NCT07325721.

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 5 Feb 2026.

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