NCT05496959Active, not recruitingPhase 2
177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study
177-Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (Lunar)
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not harm normal cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving 177-Lutetium-PSMA before SBRT may make the SBRT more effective.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 8 Aug 2022
- Start date
- 2 Sept 2022
- Primary completion date
- 1 Sept 2032
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT05496959
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 93
- From 2 Sept 2022 to the primary completion date, 1 Sept 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received androgen deprivation therapy within 6 months of trial enrollment
- Concurrent systemic therapy for a solid organ malignancy
Other illness
- Known hypersensitivity to components of 177Lu-PNT2002
- De novo oligometastatic disease
Lab values
- Patients with castrate-resistant disease (i.e., PSA \> 0.5 ng/mL with serum testosterone \< 150 ng/dL)
- 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)
Other
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Spinal cord compression
- Inability to lie flat
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.