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Double radiation attack shows promise for returning prostate cancer

NCT ID NCT05133440

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a radioactive drug (radium-223) to standard targeted radiation (SBRT) can delay cancer progression in men whose prostate cancer has returned in a few bone spots but hasn't yet become hormone-resistant. Twelve men participated, receiving either the combination or SBRT alone. The goal was to see if the combo could keep the cancer from growing longer.

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

12 people

The number who actually took part.

Started

Nov 2021

Finished

Apr 2026

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: * Biopsy proven prostate adenocarcinoma * ≥ 18 years old * Primary prostate tumor must have been treated with prior prostatectomy or definitive radiotherapy * Men with prior salvage radiotherapy to the prostate bed and/or locoregional lymph nodes are eligible assuming normalization of testosterone * Negative multi-parametric MRI and/or negative biopsy of the prostate (or prostate bed) within 60 days of enrollment * Pre-enrollment imaging (any bone imaging modality per institutional standard of care) demonstrates oligometastatic disease with 1-3 discrete metastatic lesions of the bone performed within 60 days of study enrollment; screening PSMA PET confirming 1-3 sites of oligometastatic disease performed within 60 days of enrollment. * All bony oligometastatic sites must be deemed appropriate to receive 3 fraction SBRT to a dose of 9 Gy x 3 at best judgment of treating radiation oncologist * Prostate specific antigen (PSA) ≥ 0.5 ng/mL but ≤ 50 ng/mL * Patients may have had prior androgen deprivation therapy (ADT) but must have normal testosterone levels (\>100 ng/dL) at time of enrollment; patients with baseline low testosterone but no ADT exposure are eligible * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Subjects who have not had surgical removal of their prostate and have a partner of child bearing potential must agree to use condoms beginning at the signing of the consent until at least 6 months after the last dose of study drug. Because of the potential side effect on spermatogenesis associated with radiation, female partners of childbearing potential must agree to use a highly effective contraceptive method during and for 6 months after completing treatment. Examples of highly effective contraception options for women include implantable uterine devices (hormonal or non-hormonal), oral, patch and parenteral contraceptives (when taken as prescribed). * Adequate hematological, liver and renal function * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 10.0 g/dL * Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Creatinine ≤ 1.5 x ULN with normal creatinine clearance * Albumin \> 25 g/L * Patient willing and able to comply with the protocol, including follow-up visits and examination Exclusion Criteria: * Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology * Any metastatic site \>5 cm in maximum diameter * Patients with documented castration resistant prostate cancer (CRPC) * Patients with any form of conventional, metabolic or molecular imaging (including PET imaging with PSMA, fluciclovine and/or FDG tracers) within 60 days of enrollment that demonstrate more than 3 discrete metastatic lesions * Patients with evidence of nonpelvic lymph nodal or any visceral metastases * Patients with evidence of progressing locoregional lymph nodes (prior lymphadenectomy or definitive/salvage RT to the pelvic lymph nodes is acceptable assuming no evidence of progression) * Patients with documented or suspected impending significant spinal cord compression defined as epidural spinal cord compression (ESCC) grade 2 or higher using the Bilsky scale * Patients with parenchymal brain metastases * Patient received any other investigational therapeutic agents or other anticancer therapeutics within 4 weeks prior to randomization * Major surgery within 30 days prior to start of study drug * Any prior systemic therapy with radionuclide agents (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188 or Radium (Ra-223) dichloride) for the treatment of bony metastases * Fecal incontinence * History of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer * Any other serious illness or medical condition, such as but not limited to: * Any infection greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0 Grade 2 * New York Heart Association (NYHA) Class III or IV heart failure * Crohn's disease or ulcerative colitis * Bone marrow dysplasia or myelodysplastic syndrome

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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

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

  • University of Colorado (Data Collection Only)

    Aurora, Colorado, 80045, United States

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