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Oligometastatic Prostate CarcinomaPhase 2LUNARNCT05496959

177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study

A Phase 2 study testing Lutetium Lu-177 PNT2002, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Oligometastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lutetium Lu-177 PNT2002, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteUnited States
Study dates
2 Sep 2022to 1 Sep 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: 177-Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (Lunar)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess progression-free survival for men with oligorecurrent prostate cancer after stereotactic body radiotherapy (SBRT) versus SBRT plus neoadjuvant lutetium Lu-177 PNT2002 (177Lu-PNT2002), with progression defined on the basis of prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT) scans obtained at standard intervals (12 months and 24 months post-SBRT) or at the time of prostate-specific antigen (PSA)-based biochemical progression, or initiation of salvage therapy or death.

SECONDARY OBJECTIVES:

  1. To evaluate disease burden of disease (including local control of irradiated lesions and presence of other disease) on a PSMA PET/CT obtained 24 months after SBRT of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease who have not progressed by that point.

II. To assess physician-scored toxicity (Common Terminology Criteria for Adverse Events version 5.0 [CTCAE v 5.0]) of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.

III. To assess patient-reported quality of life (based on the brief pain inventory scale) after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.

IV. To assess androgen deprivation therapy (ADT)-free survival after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.

  1. To determine local control of irradiated lesion at 12 months after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease (based on a scheduled PSMA-PET).

VI. To assess time to locoregional progression, time to distant progression, time to new metastasis, and duration of response after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease (based on standard of care imaging).

CORRELATIVE OBJECTIVES:

  1. To enumerate circulating tumor cells (CTCs) and circulating tumor deoxyribonucleic acid (ctDNA) at baseline, 3 months, 6 months, and 12 months after SBRT.

II. To quantitatively sequence T-cell receptor (TCR) repertoires using peripheral blood monocytes at baseline, 3 months, 6 months, and 12 months after SBRT.

III. To perform radiomics analysis on PSMA PET/CT scans performed at +12 months (mo.), +24 months post-SBRT, or at time of progression.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: 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.

ARM 2: Patients receive 177Lu-PNT2002 intravenously (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.

After completion of study treatment patients are followed up at 1, 3, 6, 9, and 12 months, then every 6 months until 60 months of total follow-up.

Being tested
Lutetium Lu-177 PNT2002, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutetium Lu-177 PNT2002Drug

    Also called 177Lu-labeled PNT2002, 177Lu-PNT2002, [Lu-177]-PNT2002, [Lu-177]-PSMA-I and T

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

Study groups in NCT05496959
Study groupRoleWhat they receive
Arm 1 (SBRT)Active comparatorBeginning 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.
Receives: Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy
Arm 2 (177Lu-PNT2002, SBRT)ExperimentalPatients 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.
Receives: Drug: Lutetium Lu-177 PNT2002; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT)-based progression-free survival (PFS)

    Will compare PSMA PET/CT-based PFS for patients with oligoprogressive prostate cancer treated with SBRT to all known sites of disease on PSMA PET/CT versus patients treated with 177Lu-PNT2002 prior to SBRT to all known sites of disease. PSMA PET/CT-based progression is defined as either (a) a new lesion on PSMA PET/CT with or without a serum prostate-specific antigen (PSA) increase or (b) local progression on PSMA (> 30% increase in lesion standard uptake value [SUV] or increase of > 20% in the sum of the longest diameter of all target lesions), regardless of new lesions, and a serum PSA increase. A serum PSA increase for the purposes of this definition will be based on the definition of PSA-based progression. The Kaplan-Meier (KM) method will be used to summarize PFS and log-rank test will be used to compare PFS between the two arms.

    Measured: Time from the date of stereotactic body radiotherapy (SBRT) completion to the date of disease progression or death, whichever happens earlier, assessed up to 24 months

Secondary outcomes (12)

  1. Disease progression

    Progression as based PSMA PET/CT scan (with progression). Will be analyzed descriptively.

    Measured: At 24 months

  2. PSA-based progression

    Defined as follows: (a) For pre-enrollment PSA < 0.5 ng/mL, PSA-based progression defined as 0.2 ng/mL increase and (b) For pre-enrollment PSA >= 0.5 ng/mL, PSA-based progression defined as 50% increase over pre-treatment value.

    Measured: Up to 24 months

  3. Incidence of adverse events (AEs)

    Acute and late physician-scored toxicity Common Terminology Criteria for Adverse Events (CTCAE version 5.0 scale). AEs will be summarized by type and grade. All patients who receive at least one fraction of SBRT in the control arm will be evaluable for toxicity from the time of their first treatment from SBRT; all patients who receive 177Lu-PNT2002 in the experimental arm will be evaluable for toxicity from the time of their first treatment with 177Lu-PNT2002.

    Measured: Up to 60 months

  4. Patient-reported quality of life as reported by the Brief Pain Inventory form

    Quality of life following SBRT versus 177Lu-PNT2002 +SBRT will be evaluated based on responses to the Brief Pain Inventory form, which will be tabulated at baseline and each follow-up visit (3 months, 6 months, 9 months and 1 year).

    The Brief Pain Inventory is a self-administered 9-item questionnaire, tabular scored from 0 - 130 with lower scores indicating a better outcome.

    Measured: Baseline up to 1 year

  5. Androgen deprivation therapy-free survival (ADT-FS)

    The KM method will be used to summarize ADT-FS.

    Measured: Time from starting treatment to the time of initiation of palliative ADT, assessed up to 60 months

  6. Time to progression

    Measured: Time from completing SBRT to the time of first documented tumor progression or new lesions by PSMA PET/CT or initiation of ADT, assessed up to 60 months

  7. Time to local progression (TTLP)

    The KM method will be used to summarize TTLP.

    Measured: Time from completing SBRT to identification of progression of treated lesions, assessed up to 60 months

  8. Time to new metastasis (TNM)

    The KM method will be used to summarize TNM.

    Measured: Time from completing SBRT to the time of a new documented tumor metastasis by PSMA PET/CT, assessed up to 24 months

  9. Overall survival (OS)

    The KM method will be used to summarize OS.

    Measured: Time from starting treatment until death due to any cause, assessed up to 60 months

  10. Local control (LC)

    The KM method will be used to summarize LC.

    Measured: Time from starting treatment until local relapse is documented by PSMA PET/CT based criteria, assessed up to 24 months

  11. Regional control (RC)

    failure in an adjacent lymph node region (for nodal targets) detected by PSMA PET/CT

    Measured: Time from starting treatment until regional relapse is documented by PSMA PET/CT based criteria, assessed up to 24 months

  12. Duration of complete response (CR) or partial response (PR)

    The KM method will be used to summarize the duration of complete or partial response.

    Measured: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that current or progressive disease is objectively documented, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start2 Sep 2022
  3. Primary completion1 Sep 2032 (estimated)
  4. Study completion1 Sep 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05496959
Sponsor's protocol ID
22-000750
Other IDs
NCI-2022-05748
Acronym
LUNAR
Status last verified
May 2026
First submitted
8 Aug 2022
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kishan 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.

    PubMed 41223345

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutetium Lu-177 PNT2002, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Oligometastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT)-based progression-free survival (PFS) (time frame: Time from the date of stereotactic body radiotherapy (SBRT) completion to the date of disease progression or death, whichever happens earlier, assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05496959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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