Precision radiation boost aims to improve prostate cancer control

NCT ID NCT01508390

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether a precise, high-dose radiation boost using CyberKnife can improve outcomes for men with high-risk prostate cancer that has not spread. Participants receive standard hormone therapy and radiation to the prostate and nearby lymph nodes, followed by a CyberKnife boost to the prostate alone. The trial tracks how long the cancer stays under control and how the treatment affects quality of life.

What this could mean

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

Active substance
CyberKnife stereotactic body radiation therapy
What this could lead to
If successful, this approach could offer a more precise radiation boost for high-risk prostate cancer, potentially improving disease control while reducing side effects.
What could go wrong
This is a small, early-phase study (35 participants) without a comparison group, so results may not be definitive. Radiation can still cause side effects like urinary or bowel issues.

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

35 people

The number who actually took part.

Started

Jun 2011

Expected to finish

Dec 2027

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

18 years and older

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. Histologically proven adenocarcinoma of the prostate 1. Gleason score (2-10) 2. Biopsy within six months of date of registration 3. Patient age \>18 years 2. Clinical stage (American Joint Committee on Cancer 7th Edition) a. T-stage determined by physical exam (Digital Rectal Exam Required) i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging b. N-stage determined using abdominopelvic CT scan and/or MRI c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes) Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan. 3. Patients must belong to one of the following risk groups: * PSA \> 20 and \< 150 and/or * Gleason 8-10 and/or * \> clinical T3a and/or * Clinical N1 OR * PSA 10 - 20 AND * Gleason 7 AND * Clinical T2b - T2c 4. Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes. 5. Prostate volume greater than 20 cc and less than 100 cc 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 7. Patient has agreed to complete questionnaires 8. Signed IRB approved informed consent 9. Patient eligible to have an MRI 10. Must be able to tolerate the confinement of an MRI procedure Exclusion Criteria: 1. No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy 2. No prior radiotherapy to the pelvis 3. No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery 4. No metastatic disease, with the exception of lymph node positive disease 5. No chemotherapy for a malignancy in the last 5 years. 6. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years. 7. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain 8. No history of a pelvic or horseshoe kidney 9. No diagnosis of inflammatory bowel disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

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