Radioactive drug combo shows promise for advanced prostate cancer
NCT ID NCT03361735
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a combination of radium-223 (a radioactive drug that targets bone tumors), hormone therapy, and precise radiation for men with prostate cancer that has spread to a few other places in the body. The goal is to see if this triple approach can delay cancer progression better than standard treatments. The study enrolled 25 participants and is no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radium Ra 223 dichloride (a radioactive drug that targets bone tumors)
- What this could lead to
- If successful, this combination could offer a new way to delay cancer progression in men with prostate cancer that has spread to a few spots in the body.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply to everyone. The treatment involves radiation and hormone therapy, which can cause side effects like fatigue, bone pain, and hormonal changes.
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
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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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25 people
The number who actually took part.
- Started
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Aug 2018
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- 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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Anyone
- 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: * Documented informed consent of participant and/or legally authorized representative * Agreement to provide archival primary or metastatic tumor tissue if available * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Life expectancy \> 12 months * Histologic diagnosis of prostate adenocarcinoma \* Pure small cell carcinoma will be excluded; however, component of neuroendocrine /small cell differentiation will be allowed provided that adenocarcinoma constitutes majority of the tissue specimen * Stage M1 \* Metastatic disease can be documented by bone scan or computed tomography (CT) scan or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT or the combination of these tests * Up to 4 metastatic lesions: * Must have at least 1 bone lesion AND each non-visceral lesion should be less than 5 cm * Visceral lesions will be limited to one lung lesion (\< 2 cm) or one lymph node; no liver lesions allowed; lymph nodes allowed provided they are not in a field of prior radiation, and if amenable to SBRT (to be reviewed by principal investigator \[PI\]) * Two lesions can be in close proximity (i.e. within 5 cm of each other) if they meet radiation SBRT normal tissue toxicity requirements * If have untreated primary prostate cancer: must undergo debulking prostatectomy * If had prior definitive radiation therapy to the prostate: no evidence of locally persistent or recurrent prostate cancer on digital rectal exam (DRE) and imaging studies (CT or MRI); retreatment to local residual-recurrent disease will result in potential eligibility to be reviewed by PI on a case-by-case basis * Does not have castration resistant disease \* Castration resistance defined as progression of disease despite serum testosterone level of \< 50 ng/dL * PSA \>= 0.2 prior to start of androgen deprivation treatment * Initiated 28 (+ 7) days of androgen deprivation therapy (ADT) prior to day 1 of protocol therapy \* Only luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count * May have received prior hormonal therapy in the context of definitive treatment of a primary tumor \* Patients may have had one prior systemic non-chemotherapeutic treatment (i.e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiating agent) for recurrent or metastatic disease * Must have refused standard of care chemotherapy for metastatic disease * Recovered from all acute side-effects (except alopecia) related to previous systemic therapy * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy) \* NOTE: growth factor support is not permitted to normalize baseline ANC parameters, however subsequent growth factor administration is permitted as standard supportive care * Platelets \>= 100,000/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy) \* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines * Hemoglobin (HgB) \>= 9.0 g/dL (to be performed within 14 days prior to day 1 of protocol therapy) \* NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines * Total serum bilirubin =\< 2 x upper limit of normal (ULN) (to be performed within 14 days prior to day 1 of protocol therapy) * Aspartate aminotransferase (AST) =\< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy) * Alanine aminotransferase (ALT) =\< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy) * Creatinine =\< 2.5 mg/dL (to be performed within 14 days prior to day 1 of protocol therapy) Exclusion Criteria: * Prior radium Ra 223 dichloride * Prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions: * Prior chemotherapy for local primary disease is permitted * Bisphosphonates or receptor activator of nuclear factor kappa-Β (RANK) ligand inhibitors are allowed at doses and schedule consistent with the treatment or prevention of osteoporosis * Prior radiation treatment for metastatic disease * Concomitant radiation treatment to primary prostate site * Orchiectomy * Unstable medical comorbidities (i.e. uncontrolled cardiac comorbidities) * Metastases that in the judgment of investigator-radiologist are not amenable to SBRT * History of brain metastases or who currently have treated or untreated brain metastases * Uncontrolled human immunodeficiency virus (HIV) infection * Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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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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City of Hope Medical Center
Duarte, California, 91010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can 3D imaging make prostate radiation more precise and worth the cost?
- Can surgery boost control of spread prostate cancer?