Double radiation attack shows promise for returning prostate cancer
NCT ID NCT05133440
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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12 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Apr 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
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University of Colorado (Data Collection Only)
Aurora, Colorado, 80045, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?