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Metastatic Castration-resistant Prostate CancerPhase 2ReaLuPNCT06866938

Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer

A Phase 2 study testing [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) in people with Metastatic Castration-resistant Prostate Cancer, run by Hospices Civils de Lyon at 16 sites in France.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Prostate cancer is the third leading cause of cancer-related death in men in the United States and Europe. The treatment of metastatic castration-resistant prostate cancer (mCRPC) has evolved with the arrival of the radioligand [177Lu]Lu-PSMA-617, which specifically targets PSMA-expressing cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
[177Lu]Lu-PSMA-617 (Pluvicto, Novartis)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
16 sitesFrance
Study dates
11 Apr 2025to Apr 2030
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 assessed within 7 days of study treatment initiation
  • Histologically or cytologically confirmed adenocarcinoma of prostate (Patients with small cell carcinoma of the prostate may be included)
  • Metastatic disease documented by at least one lesion on bone scan or abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Patients without bone metastasis must have measurable lesions in extra-pelvic lymph nodes or in soft-tissues as defined by RECIST 1.1 criteria
  • Confirmed progression mCRPC despite ongoing androgen deprivation with serum testosterone < 50ng/dl (1.7nM) within 3 months prior to screening. Progression is defined by the presence of at least one of the following criteria :
  • PSA progression using local laboratory values as defined by a minimum of 2 consecutive rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥1 ng/mL
Show all 27Show fewer
  • Radiographic disease progression in bone based on PCWG3 criteria defined as the appearance of 2 or more new bone lesions on bone scan, with or without PSA progression
  • Radiographic disease progression in extra-pelvic lymph nodes based or soft-tissues on RECIST1.1 criteria with or without PSA progression
  • PSMA positive metastatic lesions on [68Ga]-PSMA-PET/CT without PSMA negative lesion (The presence of PSMA-positive lesions is defined as [68Ga]-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system. The presence of PSMA-negative lesions is defined as PSMA uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis. Patients with any PSMA negative metastatic lesion meeting these criteria are ineligible).
  • Participants must have been previously treated with at least 4 consecutive cycles of [177Lu]Lu-PSMA with no evidence of progression during this first course of treatment (including radiological, clinical but also PSA progression).
  • Participants must have been previously treated with at least one ARSI - Androgen Receptor Signaling Inhibitors - (including enzalutamide, apalutamide, abiraterone or darolutamide) initiated for mCSPC, nmCRPC or mCRPC. (ARSI may be also administered together with [177Lu]Lu-PSMA-617 provided that the patient has not received an identical ARSI in the past and that this ARSI was initiated at least 15 days before the first cycle of [177Lu]Lu-PSMA-617 and less than 2 months ago. The ARSI administrated in association with LuPSMA should not be considered as a prior therapy. A previous ARSI treatment is mandatory for patient eligibility)
  • Patients must have been previously treated with at least one taxane based chemotherapy (with docetaxel or cabazitaxel) (The number of previously administrated lines of taxane-based therapy is not limited ; patients can have received a taxane-based chemotherapy before or after the first sequence of [177Lu]Lu-PSMA)
  • Patients must have been progressed at least 120 days after the last injection of the first course of [177Lu]Lu-PSMA therapy. (Patients with a radiological or clinical progressive disease during the first 120 days after the last cycle of the first course of [177Lu]Lu-PSMA are not eligible. PSA progression is defined by a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the NADIR and confirmed by a second consecutive value obtained 3 or more weeks later. Patients treated with chemotherapy, ARSI or PARP inhibitors between the first 117LuPSMA course and screening are also eligible).
  • Be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary medical cause) until 98 days (14 weeks) post-treatment.
  • Adequate organ functions :
  • Bone marrow reserve :
  • ANC ≥ 1.5 X 109/L
  • Platelets ≥ 100 X 109/L
  • Hemoglobin ≥ 10 g/dL
  • Hepatic :
  • Total bilirubin ≤ 2 x ULN. For patients with known Gilbert's syndrome ≤ 3 x ULN.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 x ULN
  • Renal :
  • Clearance ≥40 ml/mn
  • Patients must have signed informed consent prior to participating in any study related procedures
  • Willing and able to comply with the protocol, including follow-up visits and examinations
  • Patients have to be affiliated to the French social security system, or equivalent

Who cannot join

  • History of a [177Lu]Lu-PSMA serious adverse event (SAE) or CTCAE Grade 3 or 4 AE during the initial course of [177Lu]Lu-PSMA that led to the discontinuation of treatment
  • More than one course of [177Lu]Lu-PSMA therapy
  • Less than 120 days from the last dose administrated in the initial course of [177Lu]Lu-PSMA treatment and the radiological or clinical disease progression, or the initiation of a subsequent therapy.
  • Any history of treatment with radium-223 dichloride or other systemic radiotherapy (including strontium-89, samarium-153, actinium-PSMA...)
  • Transfusion of red blood cells within 30 days prior to the first injection of the re-treatment of [177Lu]Lu-PSMA-617
  • Current central nervous system (CNS) metastases
Show all 16Show fewer
  • Hypersensitivity to the active substance (Lutetium [177Lu] vipivotide tetraxetan or Gallium [68Ga] gozetotide) or to any of the excipients
  • Prior > hemibody external radiotherapy
  • Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated
  • Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
  • Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
  • Ongoing participation in any other clinical trial who may interfere with the present study in the judgment of the investigator
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
  • Active clinically significant cardiac disease
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
  • Patients under tutorship or guardianship

Trial locations and contacts

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

Denis MAILLET, Prof; MD/PhD contact

04 78 86 43 85 ext. +33

Denis.maillet@chu-lyon.fr

16 sites in 1 country

France16 sites, 16 recruiting

  • Médecine Nucléaire, Institut Bergonié

    Bordeaux, 33000

    Paul SCHWARTZ, MD, 05 56 33 04 67 ext. +33, p.schwartz@bordeaux.unicancer.fr

    Paul SCHWARTZ, MD

    Not yet recruiting

  • Oncologie Médicale, CHU Brest-Hôpital Morvan

    Brest, 29200

    Benjamin AUBERGER, MD, 02 98 22 33 95 ext. +33, benjamin.auberger@chu-brest.fr

    Benjamin AUBERGER, MD

    Not yet recruiting

  • Hôpital Louis Pradel, Hospices Civils de Lyon

    Bron, 69500

    Choaib LACHACHI, MD, +33472356999, choaib.lachachi@chu-lyon.fr

    Choaib LACHACHI, MD

    Not yet recruiting

  • Oncologie Médicale, Centre François Baclesse

    Caen, 14076

    Florence JOLY, MD, 02 31 45 50 02 ext. +33, f.joly@baclesse.unicancer.fr

    Florence JOLY, MD

    Not yet recruiting

  • Oncologie Médicale, Centre Jean Perrin

    Clermont-Ferrand, 63011

    Hakim MAHAMMEDI, MD, 04 73 27 80 80 ext. +33, Hakim.MAHAMMEDI@clermont.unicancer.fr

    Hakim MAHAMMEDI, MD

    Not yet recruiting

  • Médecine Nucléaire, Centre Hospitalier de Grenoble Alpes

    Grenoble, 38043

    Loïc DJAÏLEB, MD/PhD, 04 76 76 54 55 ext. +33, ldjaileb@chu-grenoble.fr

    Loïc DJAÏLEB, MD/PhD

    Not yet recruiting

  • Médecine Nucléaire, Centre Léon Berard

    Lyon, 69373

    Anne-Laure GIRAUDET, MD/PhD, 04 69 85 60 01 ext. +33, annelaure.giraudet@lyon.unicancer.fr

    Anne-Laure GIRAUDET, MD/PhD

    Not yet recruiting

  • Médecine Nucléaire, CHU de Nantes Hôtel-Dieu

    Nantes, 44000

    Clément BAILLY, MD, 02 40 08 41 36 ext. +33, clement.bailly@chu-nantes.fr

    Clément BAILLY, MD

    Not yet recruiting

  • Oncologie Médicale, Centre Antoine Lacassagne

    Nice, 06189

    Delphine BORCHIELLINI, MD, 04 92 03 15 14 ext. +33, delphine.borchiellini@nice-unicancer.fr

    Delphine BORCHIELLINI, MD

    Not yet recruiting

  • Institut de cancérologie du Gard

    Nîmes, 30000

    Nadine HOUEDE, MD, +334 66 68 32 31, nadine.houede@chu-nimes.fr

    Nadine HOUEDE, MD

    Not yet recruiting

  • Oncologie Médicale, Centre Hospitalier Lyon Sud, HCL

    Pierre-Bénite, 69310

    Denis MAILLET, Prof; MD/PhD, 04 78 86 43 85 ext. +33, Denis.maillet@chu-lyon.fr

    Denis MAILLET, Prof; MD/PhD

    Recruiting

  • Oncologie Médicale, Centre Henri Becqueret

    Rouen, 76038

    Laetitia AUGUSTO, MD, 02 32 08 25 75 ext. +33, laetitia.augusto@chb.unicancer.fr

    Laetitia AUGUSTO, MD

    Not yet recruiting

  • Oncologie Médicale, CHU Saint Etienne

    Saint-Priest-en-Jarez, 42270

    Pierre-Benoit BONNEFOY, MD, 04 77 91 70 82 ext. +33, p.benoit.bonnefoy@chu-st-etienne.fr

    Pierre-Benoit BONNEFOY, MD

    Not yet recruiting

  • Médecine Nucléaire, Institut de Cancérologie de Strasbourg

    Strasbourg, 67200

    François SOMME, MD, 03 68 76 67 67 ext. +33, f.somme@icans.eu

    François SOMME, MD

    Not yet recruiting

  • CHU de Nancy

    Vandœuvre-lès-Nancy, 54511

    Marine CLAUDIN, MD, +333 83 15 71 72, m.claudin@chru-nancy.fr

    Marine CLAUDIN, MD

    Not yet recruiting

  • Médecine Nucléaire, Institut Gustave Roussy

    Villejuif, 94800

    Desirée DEANDREIS, MD/PhD, 01 42 11 42 77 ext. +33, desiree.deandreis@gustaveroussy.fr

    Desirée DEANDREIS, MD/PhD

    Not yet recruiting

Other trials in France

About this study

Official title: An Open Label, Single Arm Phase IIb Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer

Prostate cancer is the third leading cause of cancer-related death in men in the United States and Europe. The treatment of metastatic castration-resistant prostate cancer (mCRPC) has evolved with the arrival of the radioligand [177Lu]Lu-PSMA-617, which specifically targets PSMA-expressing cancer cells.

The randomized phase III VISION study showed that [177Lu]Lu-PSMA-617 significantly improved progression-free survival and overall survival with an acceptable toxicity profile.

Read more

The ReaLuP study will evaluate the efficacy of a re-treatment of [177Lu]Lu-PSMA-617 in patients with progressive PSMA-positive mCRPC and who have been previously treated with [177Lu]Lu-PSMA without evidence of progression during this first course of treatment.

Patients will be treated until disease progression, unacceptable toxicity or death, or alternatively up to 9 months after the last dose of treatment.

At the end of this follow up period, patients will enter the " long term follow up ", at least for 2 years after the end of the last active follow-up.

Being tested
[177Lu]Lu-PSMA-617 (Pluvicto, Novartis)
Keywords
Metastatic castration resistance prostate cancer, Internal vectorized radiotherapy, [177Lu]Lu-PSMA rechallenge

What participants receive

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

  • [177Lu]Lu-PSMA-617 (Pluvicto, Novartis)Drug

    Patients will be treated with intravenous [177Lu]Lu-PSMA-617 (Pluvicto, Novartis).

    One injection every 6 weeks at the dose of 7.4 GBq (±10%)

Study groups in NCT06866938
Study groupRoleWhat they receive
[177Lu]Lu-PSMA-617ExperimentalPatients with metastatic castration resistance prostate cancer will be treated with intravenous [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) at the dose of 7.4 GBq (±10%) every 6 weeks Treatment duration: 4 to 6 cycles (24 to 36 weeks)
Receives: Drug: [177Lu]Lu-PSMA-617 (Pluvicto, Novartis)

What is being measured

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

  1. Progression-Free Survival rate

    Proportion (in %) of patients alive without disease progression at 24 weeks. Progression is defined by imaging (bone scan and CT-scan) according to RECIST 1.1 and/or PCWG3 criteria.

    Measured: At 24 weeks after the start of study treatment

Secondary outcomes (12)

  1. Imaging-based radiographic progression (rPFS)

    Imaging-based radiographic progression defined as the time from the first cycle of re-treatment to the date of radiographic disease progression or death from any cause.

    Measured: Through study completion, a maximum of 57 months

  2. Overall survival

    Overall Survival (Os) defined as the time from the first cycle of re-treatment to the date of death from any cause

    Measured: Through study completion, a maximum of 57 months

  3. Objective response rate

    Objective response rate (ORR) (Complete Response (CR) + Partial Response (PR)) measured by RECIST v1.1 response.

    Measured: Through study completion, a maximum of 57 months

  4. Duration of response

    Duration of response (DOR) will be measured in patients who achieved a CR or PR between the date of first response and the date of RECIST progression or death.

    Measured: Through study completion, a maximum of 57 months

  5. Disease Control Rate

    Disease control rate as measured by RECIST v1.1 response. Rates will be measured in soft tissue, lymph nodes and visceral lesions.

    Measured: Through study completion, a maximum of 57 months

  6. Progression free survival

    Progression free survival will be defined as the date of first cycle of [177Lu]Lu-PSMA-617 re-treatment to the date of first evidence of radiographic progression, clinical progression, PSA progression, or death from any cause, whichever occurs first.

    Measured: Through study completion, a maximum of 57 months

  7. Biological response

    Proportion of participants with a PSA response defined as a patient who has achieved a ≥ 50% PSA decrease from baseline that is confirmed with a second PSA measurement at ≥ 4 weeks.

    Measured: Through study completion, a maximum of 57 months

  8. Time to PSA progression

    Time to PSA progression will be defined as the date from first cycle of [177Lu]Lu-PSMA-617 re-treatment to a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir and confirmed by a second consecutive value obtained 3 or more weeks later. Where no decline from baseline is documented, PSA progression is defined as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks of treatment.

    Measured: Through study completion, a maximum of 57 months

  9. Safety : Adverse Events

    Safety of re-treatment will be assessed by percentage of patients with all grade and Serious AEs; percentage of patients with SAEs during the active follow up period; percentage of patients with an interruption of [177Lu]Lu-PSMA-617 re-treatment; Percentage of patients who discontinue [177Lu]Lu-PSMA-617 re-treatment secondary to an AEs or death; Number and grade of AE related to the investigational medicinal product or to the procedures added by the research

    Measured: Through study completion, a maximum of 57 months

  10. Pain assessment

    Pain will be assessed with the BPI-SF (Brief Pain Inventory - Short Form) questionnaire.

    BPI-SF is a multidimensional scale evaluating the intensity and the interference of pain in life activities: four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics.

    Pain severity: The BPI assesses pain at its "worst," "least," "average," and "now" (current pain); each of the forth items are used singly to represent pain severity.

    Pain interference: The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. This mean can be used if more than 50%, or four of seven, of the total items have been completed on a given administration.

    The highest is the score, the worst are the pain and pain interference

    Measured: Up to 6 weeks from the last [177Lu]Lu-PSMA-617 administration

  11. Quality of life assessment

    Aspects of HRQoL will be reported using Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.

    FACT-P score range 0-156; the higher the score, the better the QoL Subscales: Physical well-being (0-28) Social/Family well-being (0-28) Emotional well-being (0-24) Functional well-being (0-28) Prostate cancer subscale (0-48)

    Measured: Up to 6 weeks from the last [177Lu]Lu-PSMA-617 administration

  12. Symptomatic Skeletal Event (SSE) assessment

    Time to first symptomatic skeletal event (SSE) and SSE-free survival defined as date of first injection of [177Lu]Lu-PSMA-617 re-treatment to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, or requirement for radiation therapy to relieve bone pain, whichever occurs first.

    Measured: Through study completion, a maximum of 57 months

Timeline

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

  1. First posted10 Mar 2025
  2. Study start11 Apr 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2030 (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
Model description
Prospective multicenter phase IIb single arm non randomized open-label study.
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06866938
Sponsor's protocol ID
69HCL24_0183
Other IDs
2024-512043-22-00
Acronym
ReaLuP
Status last verified
Jan 2026
First submitted
26 Feb 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) in people with Metastatic Castration-resistant Prostate Cancer, run by Hospices Civils de Lyon at 16 sites in France.

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 27 inclusion and 16 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. 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 Denis MAILLET, Prof; MD/PhD (04 78 86 43 85 ext. +33, Denis.maillet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival rate (time frame: At 24 weeks after the start of study treatment). 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 NCT06866938.

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 6 Jan 2026.

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