New combo attack on returning prostate cancer shows promise in early trial
NCT ID NCT05496959
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether giving a radioactive drug (177Lu-PSMA) before precise radiation (SBRT) can better control prostate cancer that has come back in 1 to 5 spots. About 93 men with recurrent prostate cancer will receive either SBRT alone or the drug first, then SBRT. The goal is to see if the combination delays cancer progression more effectively.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lutetium Lu-177 PNT2002 (a radioactive drug that targets prostate cancer cells)
- What this could lead to
- If it works, this combination could offer a more effective way to control prostate cancer that has returned in a few spots, potentially delaying further spread.
- What could go wrong
- This is a mid-stage trial with only 93 people, so results may not apply to everyone. The treatment involves radiation, which can cause side effects like fatigue or damage to nearby organs.
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
-
93 people
The number who actually took part.
- Started
-
Sep 2022
- Expected to finish
-
Sep 2033
An estimate. End dates often move.
- 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
-
Anyone
- 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 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: * Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * No indication for urgent or emergent radiation * Histologic confirmation of prostate adenocarcinoma (histology from original treatment acceptable) * White blood cell count \>= 2.5 × 10\^9/L * Platelets \>= 100 × 10\^9/L * Hemoglobin \>= 9 g/dL * Total bilirubin =\< 1.5 × institutional upper limit of normal (ULN); or up to 3 × ULN if known history of Gilbert's syndrome * Alanine aminotransferase or aspartate aminotransferase =\< 3.0 × ULN or =\< 5.0 × ULN for patients with liver metastases * Serum creatinine =\< 1.5 × ULN or creatinine clearance \>= 50 mL/min * Serum albumin \> 3.0 g/dL * Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration * Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: * Patients with neuroendocrine or small cell carcinoma of the prostate * Patients with castrate-resistant disease (i.e., PSA \> 0.5 ng/mL with serum testosterone \< 150 ng/dL) * Patients who received androgen deprivation therapy within 6 months of trial enrollment * Concurrent systemic therapy for a solid organ malignancy * Spinal cord compression * Inability to lie flat * Known hypersensitivity to components of 177Lu-PNT2002 * Serum creatinine \> 1.5 × ULN or creatinine clearance \< 50 mL/min * Total bilirubin \> 1.5 × ULN or \> 3.0 × ULN if known history of Gilbert's syndrome * Alanine aminotransferase or aspartate aminotransferase \> 3 × ULN (or 5 × ULN for patients with known liver metastases) * De novo oligometastatic disease
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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
-
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Can engineered immune cells take down advanced prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?