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Castration-Resistant Prostate CarcinomaPhase 2NCT06288113

Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Gallium Ga 68 Gozetotide in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to… Read more about this study

Who is it for?
Any age, men only
What is being tested?
Biospecimen Collection, Computed Tomography and Gallium Ga 68 Gozetotide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Aug 2024to 27 Jan 2028
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must have mCRPC
  • Patients must have received at least one regimen of chemotherapy for mCRPC
  • Patients must have received at least one androgen receptor signaling inhibitor (ARSI)
  • Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy
  • Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as:
  • PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND
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  • No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy [ADT] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
  • Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart
  • Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy
  • White blood cells > 2,500 cells/µL
  • Absolute neutrophil count > 1,500 cells/µL
  • Hemoglobin > 9.0 g/dL
  • Platelets > 100,000 cells/µL
  • Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements

Who cannot join

  • Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
  • Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks
  • Patient with creatinine clearance < 50 mL/min

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stephanie Lira contact

3102060596

StephanieLira@mednet.ucla.edu

Ethan Lam contact

3102067372

clam@mednet.ucla.edu

United States1 site, 1 recruiting

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Ethan Lam, 310-206-7372, clam@mednet.ucla.edu

    Stephanie Lira, 3102060596, StephanieLira@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

Official title: Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)

This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the treatment efficacy of re-challenge lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) therapy (for a maximum of 6 additional cycles) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had a favorable response to a prior regimen of 177Lu-PSMA-617 therapy.

SECONDARY OBJECTIVES:

  1. To determine the safety of re-challenge 177Lu-PSMA-617 therapy by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

II. To determine the rate of patients who have a prostate-specific antigen (PSA) response (defined as a PSA decline of ≥ 50% during re-challenge 177Lu-PSMA-617 therapy).

III. To determine biochemical progression-free survival (PFS) according to Prostate Cancer Working Group 3 (PCWG3) guidelines.

IV. To determine overall survival (OS) from the start (cycle 1 day 1) of the first regimen of 177Lu-PSMA-617 therapy.

  1. To determine OS from the end (day 1 of the final cycle) of the first regimen of 177Lu-PSMA-617 therapy.

VI. To determine radiographic progression-free survival (rPFS) according to Response Evaluation Criteria in PSMA positron emission tomography (PET)/computed tomography (CT) (RECIP) criteria.

VII. To determine the impact of re-challenge 177Lu-PSMA-617 therapy on bone pain level, health-related quality of life, and performance status (Eastern Cooperative Oncology Group [ECOG]) using established standardized questionnaires.

EXPLORATORY OBJECTIVE:

  1. To determine the dosimetry in organs and tumor lesions of re-challenge 177Lu-PSMA-617 therapy using a 24-hour single-time-point dosimetry protocol.

OUTLINE:

Patients receive 177Lu-PSMA-617 intravenously (IV) on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo single photon emission computed tomography (SPECT)/CT on study, and undergo collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up within 8 weeks of their last treatment cycle and then every 3 months for up to a total of 2 years.

Being tested
Biospecimen Collection, Computed Tomography, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, Positron Emission Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT and SPECT/CT

  • Gallium Ga 68 GozetotideOther

    Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC

    Given IV

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT/CT

Study groups in NCT06288113
Study groupRoleWhat they receive
Treatment (177Lu-PSMA-617)ExperimentalPatients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Gallium Ga 68 Gozetotide; Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Single Photon Emission Computed Tomography

What is being measured

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

  1. 12-month overall survival

    12-month overall survival (OS) of patients with mCRPC who previously had a favorable response to a first regimen of 177Lu-PSMA-617 and are treated with re-challenge 177Lu-PSMA-617 therapy

    Measured: Assessed at 12 months

Secondary outcomes (10)

  1. Incidence of adverse events (AEs)

    Overall and grade ≥ 3 AEs will be defined and graded according to Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to report the number and percentage of patients who experience AEs during re-challenge therapy. Separate statistics will be reported for grade ≥ 1 AEs and for grade ≥ 3 AEs. These descriptive statistics will be presented for the whole treatment as well as separately for each cycle. In addition, the relationship of AE to the study drug (related versus not related) will be reported. Results from laboratory test, physical examinations, and patient surveys will be used.

    Measured: Assessed approximately at 2 years

  2. Rate of prostate specific antigen (PSA) response

    Will be defined as a PSA decline of ≥ 50% during re-challenge therapy on two measurements ≥ 3 weeks apart. Descriptive statistics will be used to report the number and percentage of patients who had a PSA response to re-challenge therapy. The number and percentage of patients with any decrease in serum PSA level compared to the baseline PSA at time of study enrollment will be reported as well.

    Measured: Assessed approximately at 36 weeks

  3. Biochemical progression-free survival (PFS)

    Will be evaluated using Prostate Cancer Working Group 3 guidelines.

    Measured: Assessed approximately at 2 years

  4. Overall Survival from start of first regimen

    To determine OS from the start of the first regimen of 177Lu-PSMA-617 therapy (Cycle 1 Day 1) (each cycle is 6 weeks) through study completion.

    Measured: Assessed approximately at 2 years

  5. Overall survival from the end of the first regimen

    To determine OS from the end of the first regimen of 177Lu-PSMA-617 therapy (Day 1 of the final cycle) (each cycle is 6 weeks) through study completion.

    Measured: Assessed approximately at 2 years

  6. Radiographic progression-free survival (rPFS)

    To determine radiographic progression-free survival (rPFS) according to Response Evaluation Criteria in PSMA PET/CT (RECIP) criteria through study completion.

    Measured: approximately two years.

  7. Bone Pain

    Proportion of patients who initially had bone pain who experienced pain response with re-challenge 177Lu-PSMA-617 therapy

    Measured: approximately 36 weeks.

  8. Changes in health-related quality of life_Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT).

    The Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) is a patient-reported outcome (PRO) tool designed to measure symptoms and toxicities among prostate cancer patients receiving radionuclide therapy (RNT). The total score can range from 0 to 60, with higher scores indicating better quality of life and fewer symptoms or side effects related to radionuclide therapy (RNT).

    Measured: approximately 36 weeks.

  9. Changes in health-related quality of life_Brief Pain Inventory Short form

    Pain response will be evaluated as at least a 2-point improvement from baseline without an overall increase in opiate use. evaluated using Brief Pain Inventory Short form (BPI-SF). The Brief Pain Inventory Short Form (BPI-SF) is a widely used tool for assessing pain severity and its impact on daily life. Ratings are on a scale from 0 (does not interfere) to 10 (completely interferes).

    The Pain Interference Score is the mean of these seven interference ratings, with a lower score being better.

    Measured: approximately 36 weeks.

  10. Changes in health-related quality of life_ Eastern Cooperative Oncology Group score

    To determine the impact of re-challenge 177Lu-PSMA-617 therapy on performance status using Eastern Cooperative Oncology Group score (ECOG) through re-challenge therapy completion. The ECOG Performance Status Scale is a widely used measurement in clinical oncology to assess a patient's level of functioning. It helps describe how a patient's disease impacts their daily living abilities. the ECOG scale ranges from 0 to 5. with a lower score indicating better daily living ability.

    Measured: approximately 36 weeks.

Timeline

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

  1. First posted1 Mar 2024
  2. Study start1 Aug 2024
  3. Primary completion27 Jan 2027 (estimated)
  4. Study completion27 Jan 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06288113
Sponsor's protocol ID
23-001509
Other IDs
NCI-2024-00310, 23-001509
Status last verified
Mar 2026
First submitted
5 Feb 2024
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nikitas J, Holzgreve A, Juarez J, Kimura K, Lira S, Alam H, Contreras M, Theus L, Nguyen AT, Ells Z, Zhu S, Grogan T, Elashoff DA, Unterrainer LM, Dahlbom M, Allen-Auerbach M, Czernin J, Calais J. Phase 2 Prospective Trial of Retreatment with [177Lu]Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration-Resistant Prostate Cancer-RE-LuPSMA. J Nucl Med. 2026 May 1;67(5):674-680. doi: 10.2967/jnumed.125.271231.

    PubMed 41679923

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Gallium Ga 68 Gozetotide in people with Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, 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 3 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: looking for participants now, as of the sponsor's last update on 13 Mar 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?

Contact Stephanie Lira (3102060596, StephanieLira@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month overall survival (time frame: Assessed at 12 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 NCT06288113, 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 13 Mar 2026.

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