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Can targeted radiation boost prostate cancer control?

NCT ID NCT03556904

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study tested whether adding focused radiation to standard hormone therapy or chemotherapy helps men with prostate cancer that has spread to a few spots (oligometastatic) and is no longer responding to hormone therapy alone. Fourteen participants received either standard treatment alone or standard treatment plus radiation. The goal was to see if the combination delays cancer growth or spread.

What this could mean

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

Active substance
Ablative radiation therapy (focused radiation) plus standard hormone therapy or chemotherapy
What this could lead to
If successful, this could show that adding focused radiation to standard treatment helps control prostate cancer that has spread to a few spots, potentially delaying progression.
What could go wrong
This is a small, early-phase trial with only 14 participants, so results may not apply broadly. The added radiation may not improve outcomes and could cause 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

14 people

The number who actually took part.

Started

Dec 2018

Finished

Jul 2023

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: * Subjects must have biopsy-confirmed adenocarcinoma of the prostate * Subjects must discontinue any prior systemic therapies (excluding GnRH agonist/antagonists) without PSA withdrawal effects if using first generation anti-androgens. Luteinizing hormone-releasing hormone (LHRH) analogues must be continued if they have not undergone orchiectomy. (Subjects who recently started systemic therapy for metastatic castration-resistant prostate cancer (mCRPC) are eligible to enroll if new therapy was started ≤ 14 days to consent date.) * Subjects must have progressive metastatic castration-resistant prostate cancer based on at least one of the following criteria while having castrate levels (\<50 ng/dL) of testosterone: * A) PSA progression defined as a 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval. * B) Progression of bidimensionally measurable soft tissue or nodal metastasis by CT scan or MRI based on RECIST criteria * C) Progression of bone disease on bone scan as defined by two new lesions arising * Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5 treatment sites that can be treated within a radiotherapy treatment field. * Subjects must be medically fit to undergo radiotherapy and systemic therapy as determined by the treating physician. * Age ≥ 18 * ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death) * No prior invasive malignancy in the past 3-years. Exceptions include non-melanomatous skin cancer and in situ cancers of the bladder or head and neck are permissible. * Subjects must freely sign informed consent to enroll in the study. * Subjects must use contraception up to 90 days after last drug dose. Exclusion Criteria: * Planned systemic therapy with Radium-223 dichloride or sipuleucel-T * Tumor requiring emergent radiation in view of provider * Life expectancy estimate of \<3 months * Presence of known parenchymal brain metastasis * Uncontrolled intercurrent illness * Inability to undergo radiotherapy, systemic treatment, CTs or bone scans * Biopsy proven pure small cell or neuroendocrine prostate cancer

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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

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105, United States

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