New radiation therapy shows promise for slowing prostate cancer spread
NCT ID NCT04443062
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a drug called Lutetium-177-PSMA-617, which delivers radiation directly to prostate cancer cells. It included 58 men with prostate cancer that had spread to a few spots in bones or lymph nodes but was still hormone-sensitive. The study compared the drug to standard care to see if it could delay disease progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lutetium-177-PSMA-617 (a targeted radioactive drug)
- What this could lead to
- If successful, this could offer a new treatment option for men with prostate cancer that has spread to a few places, potentially delaying the need for stronger hormone therapy.
- What could go wrong
- This is a small, early-phase study with only 58 participants. The treatment may not work better than standard care, and there are risks from radiation exposure to healthy tissues.
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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58 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Jan 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
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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: * Histological proven adenocarcinoma of the prostate with sufficient archived tumor material. This material has to be archived till study closure. * Biochemical recurrence (PSA \> 1.0 µg/l). * PSA-doubling time \< 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 µg/l. * 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 5 metastases. * Local treatment for oligo-metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions or if the patient refuse these treatments). * No prior hormonal therapy (including any androgen directed treatment such as finasteride, dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane based chemotherapy (docetaxel or cabazitaxel); testosterone \> 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 6 months. * A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a SUVmax \> 15 (partial volume corrected). * ECOG 0-1 * Patients must have a life expectancy \>6 months. * Laboratory values: * White blood cells \> 3.0 x 109/l * Platelet count \> 75 x 109/l * Hemoglobin \> 6.2 mmol/l * ASAT, ALAT \< 3 x ULN * MDRD-GFR ≥ 50 ml/min * Signed informed consent. Exclusion Criteria: * A known subtype other than prostate adenocarcinoma. * Previous PSMA based radioligand treatment. * Visceral or brain metastases. * Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial. * Prior hip replacement surgery potentially influencing performance of PSMA PET/CT. * Sjogren's syndrome * A second active malignancy other than prostate cancer. * Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
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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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Amsterdam UMC
Amsterdam, Netherlands
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German Oncology Center
Limassol, Cyprus
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Radboud University
Nijmegen, Netherlands
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University Medical Center Groningen
Groningen, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains