Actively Recruiting
Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
Led by Hospices Civils de Lyon · Updated on 2026-01-06
58
Participants Needed
16
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- ECOG performance status 0 to 2 within 7 days before treatment
- Histologically or cytologically confirmed prostate adenocarcinoma (small cell carcinoma allowed)
- Metastatic disease confirmed by bone scan or CT/MRI; measurable lesions if no bone metastasis
- Confirmed progression of mCRPC despite ongoing androgen deprivation with serum testosterone < 50 ng/dl
- Progression defined by PSA rise, radiographic bone progression, or soft tissue progression
- PSMA-positive metastatic lesions without PSMA-negative lesions on [68Ga]-PSMA-PET/CT
- Previously treated with at least 4 consecutive cycles of [177Lu]Lu-PSMA without progression
- Previously treated with at least one androgen receptor signaling inhibitor (ARSI)
- Previously treated with at least one taxane-based chemotherapy
- Progression at least 120 days after last [177Lu]Lu-PSMA dose
- Abstinent from heterosexual intercourse or agree to use contraception until 98 days post-treatment if fertile
- Adequate organ function (bone marrow, liver, kidney) as specified
- Signed informed consent
- Able and willing to comply with the study protocol
- Affiliated with French social security or equivalent
You will not qualify if you...
- History of serious adverse event or grade 3/4 adverse event from initial [177Lu]Lu-PSMA treatment leading to discontinuation
- More than one prior course of [177Lu]Lu-PSMA therapy
- Less than 120 days between last initial [177Lu]Lu-PSMA dose and disease progression or new therapy
- Prior treatment with radium-223 or other systemic radiotherapy
- Red blood cell transfusion within 30 days before re-treatment
- Current central nervous system metastases
- Hypersensitivity to Lutetium [177Lu] or Gallium [68Ga] compounds or excipients
- Prior extensive external radiotherapy
- Untreated or imminent spinal cord compression
- Other malignancy treated within 3 years (except certain skin or bladder cancers)
- Chronic bone conditions like Paget's disease
- Participation in interfering clinical trials
- Serious uncontrolled medical conditions
- Active significant cardiac disease
- Psychiatric or somatic conditions interfering with study
- Under legal tutorship or guardianship
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Médecine Nucléaire, Institut Bergonié
Bordeaux, France, 33000
Not Yet Recruiting
2
Oncologie Médicale, CHU Brest-Hôpital Morvan
Brest, France, 29200
Not Yet Recruiting
3
Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, France, 69500
Not Yet Recruiting
4
Oncologie Médicale, Centre François Baclesse
Caen, France, 14076
Not Yet Recruiting
5
Oncologie Médicale, Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
6
Médecine Nucléaire, Centre Hospitalier de Grenoble Alpes
Grenoble, France, 38043
Not Yet Recruiting
7
Médecine Nucléaire, Centre Léon Berard
Lyon, France, 69373
Not Yet Recruiting
8
Médecine Nucléaire, CHU de Nantes Hôtel-Dieu
Nantes, France, 44000
Not Yet Recruiting
9
Oncologie Médicale, Centre Antoine Lacassagne
Nice, France, 06189
Not Yet Recruiting
10
Institut de cancérologie du Gard
Nîmes, France, 30000
Not Yet Recruiting
11
Oncologie Médicale, Centre Hospitalier Lyon Sud, HCL
Pierre-Bénite, France, 69310
Actively Recruiting
12
Oncologie Médicale, Centre Henri Becqueret
Rouen, France, 76038
Not Yet Recruiting
13
Oncologie Médicale, CHU Saint Etienne
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
14
Médecine Nucléaire, Institut de Cancérologie de Strasbourg
Strasbourg, France, 67200
Not Yet Recruiting
15
CHU de Nancy
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
16
Médecine Nucléaire, Institut Gustave Roussy
Villejuif, France, 94800
Not Yet Recruiting
Research Team
D
Denis MAILLET, Prof; MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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