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MRI pinpoints prostate cancer recurrence for precision radiation boost

NCT ID NCT01411345

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase II trial tests whether using MRI to map the exact location of recurrent prostate cancer after prostatectomy allows doctors to safely deliver a higher radiation dose to the tumor while sparing healthy tissue. The study enrolled 37 men whose PSA levels rose after surgery. The goal is to see if this targeted approach improves PSA response rates and reduces anxiety compared to standard radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy
What this could lead to
If successful, this approach could improve control of prostate cancer recurrence after surgery by targeting higher radiation doses to tumor areas seen on MRI.
What could go wrong
This is a small, early-phase trial with only 37 participants, so results may not apply broadly. Higher radiation doses also carry increased risk of side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

37 people

The number who actually took part.

Started

Jul 2012

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 85 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 4.0 ng/mL within 3 months prior to enrollment. 2. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible. 3. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing. 4. Imaging detectable lesion or lesions in prostate bed or regional lymph node (LN). Each lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to protocol entry or enrollment. 5. No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac). 6. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment. 7. No previous pelvic radiotherapy. 8. Serum total testosterone taken within 3 months prior to enrollment. 9. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 3 years then the patient is eligible. 10. Ability to understand and the willingness to sign a written informed consent document. 11. Zubrod performance status \< 2. 12. Patients must agree to fill out quality of life/psychosocial questionnaires. 13. Age ≥ 35 and ≤ 85 years. Exclusion Criteria: a. Prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is allowed).

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate adenocarcinoma Prostate cancer

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

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