Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastatic Prostate Carcinoma | Oligometastatic Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutetium Lu-177 PNT2002 | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 (SBRT)
- description
- Beginning on day 1, patients undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Quality-of-Life Assessment
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- Arm 2 (177Lu-PNT2002, SBRT)
- description
- Patients receive 177Lu-PNT2002 IV over 1-10 minutes on days -112 and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day 1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Lutetium Lu-177 PNT2002
- Other: Quality-of-Life Assessment
- Radiation: Stereotactic Body Radiation Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKishan AU, Valle LF, Wilhalme H, Felix C, Nabong R, Juarez-Casillas JE, Flores K, Ma TM, Ludwig V, Nakayama M, Ells Z, Dahlbom M, Lauria M, Meyer C, Cao M, Weidhaas JB, Telesca D, McGreevy K, Nickols NG, Karasik D, Parmisano S, Basehart TV, Brisbane W, Marks L, Rettig MB, Reiter RE, Boutros PC, Allen-Auerbach M, Czernin J, Steinberg ML, Calais J. 177Lu-Prostate-Specific Membrane Antigen Neoadjuvant to Stereotactic Ablative Radiotherapy for Oligorecurrent Prostate Cancer (LUNAR): An Open-Label, Randomized, Controlled, Phase II Study. J Clin Oncol. 2025 Dec 20;43(36):3812-3821. doi: 10.1200/JCO-25-01553. Epub 2025 Nov 12. PMID 41223345