New combo therapy aims to stall prostate cancer spread
NCT ID NCT05893381
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether adding a radioactive drug called Lu-PSMA to precise radiation therapy can better control prostate cancer that has spread to just 1-3 spots. About 70 men with hormone-sensitive prostate cancer will be randomly assigned to get radiation alone or radiation plus Lu-PSMA. The main goal is to see if the combination delays a rise in PSA levels, a marker of cancer activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lu-PSMA (a radioactive drug) and stereotactic radiotherapy
- What this could lead to
- If it works, this combination could delay cancer progression and the need for hormone therapy in men with a few prostate cancer metastases.
- What could go wrong
- This is a phase II trial with only 70 participants, so results are not definitive. The added radioactive drug may cause side effects like dry mouth or blood cell 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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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Apr 2032
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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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: 1. Patients with prostate cancer must have 1-3 asymptomatic metastatic lesions that are ≤ 5.0 cm or \< 250 cm3 documented at CT/MRI or WBD-MRI. 2. PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI. 3. Patients must have had their primary tumor treated with surgery and/or radiation and previous salvage radiation to the prostate bed or pelvis is allowed. 4. Patients will be admitted to the therapeutic phase only if diagnostic PET/CT PSMA SUV max is ≥ 3. 5. Histologic confirmation of malignancy (primary or metastatic tumor). 6. Prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL and Testosterone ≥ 125 ng/dL. 7. PSA doubling time (PSADT) \< 15 months. PSADT will be calculated using as many PSA values that are available from time of relapse (PSA \> 0.2 ng/dL). 8. Patients unfit or refusing ADT. 9. Patients may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patients may have had ADT associated with salvage radiation therapy. 10. Patients must be ≥ 18 years of age. 11. Patient understands the purpose of the study and the procedures required for it; the patient is willing to participate in the study and to sign a written informed consent document. 12. Patients must have an Eastern Cooperative Oncology Group performance status ≤ 2. 13. Patients should have a life expectancy of at least 6 months. 14. Patients must have normal organ and marrow function as defined as: * Leukocytes \>2,000/μL; * Absolute neutrophil count \>1,000/μL; * Platelets \>75,000/μL; * total bilirubin within normal institutional limits (this will not apply to patients with confirmed Gilbert's syndrome); * AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal; * Creatinine within normal institutional limits. 15. If the participant engages in sexual activity with a woman of childbearing potential, a condom must be used together with another highly effective method of contraception during the Treatment Period and for 6 months after the last dose of study intervention. The participant must agree not to donate sperm for the purpose of reproduction during the Treatment Phase and for a minimum of 6 months after receiving the last dose of study intervention. 16. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception, see Appendix F) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months. 16\. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception, starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Exclusion Criteria: The participant may not enter the study if ANY of the following apply: 1. No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred more than 6 months prior to enrollment. 2. PSMA -PET/CT scan more than 3 months. 3. Spinal cord compression or impending spinal cord compression. 4. Suspected pulmonary and/or liver metastases. 5. Bone metastasis in a femoral bone. 6. Previous radiation therapy on the metastatic site. 7. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. A window of 3 days is permitted. 8. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. A window of 3 days is permitted. 9. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant. 10. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177-Lu-PSMA- I \& T or other agents used in the study. 12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 13. Unable to lie flat during or tolerable SABR. 14. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma); 15. Known HIV-positivity, whether or not symptomatic.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UO Medicina Nucleare, AUSL della Romagna
RECRUITINGCesena, FC, 47521, Italy
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UO Medicina Nucleare, IRCCS IRST
RECRUITINGMeldola, FC, 47014, Italy
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