Very High Risk Prostate CarcinomaPhase 1/2NEPINCT06388369
Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
A Phase 1/2 study testing [177Lu]Lu-PSMA-617 and Ipilimumab in people with Very High Risk Prostate Carcinoma, run by University Hospital, Essen at 1 site in Germany.
Trial summary
A randomized, open-label Phase I/II study of neoadjuvant treatment with [177Lu]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Very High Risk Prostate Carcinoma
- What is being tested?
- [177Lu]Lu-PSMA-617 and Ipilimumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 25 Aug 2025to 9 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Must be ≥18 years of age
- Signed an informed consent form (ICF) indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study; participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Histologically confirmed adenocarcinoma of the prostate including following criteria: Very High-risk defined by a total Gleason-Score ≥4+4 (ISUP-GG 4+5) and clinical stage cT3 (digital rectal examination or imaging based) plus clinical nodal status cN+ or Serum-PSA level >20ng/ml
- Exclusion of metastases (M0) on conventional imaging and maximum oligometastatic status on PSMA PET imaging
- Treatment naïve patients
- Eastern Cooperative Oncology Group ECOG 0-1
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- Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
- Patients must be PSMA Positron Emission Tomography (PET) scan positive with a prostatic SUVmax > 12 (PRIMARY Score: 5) .
- Following laboratory criteria must be obtained within 14 days prior to randomization:
- Bone marrow reserve
- White blood cells, WBC ≥ 2000/μL
- Neutrophils ≥ 1500/μL
- Platelets ≥ 100 x103/μL
- Hemoglobin ≥ 9.0 g/dL
- Hepatic:
- AST/ALT ≤ 3 x ULN
- Total Bilirubin ≤ 1.5 x ULN (except participants with Gilbert Syndrome, who may have total bilirubin < 3.0 mg/dL)
- Renal:
- Serum creatinine ≤ 1.5xULN
- Endocrine:
- TSH 0,4 - 4,0 mU/l = 0,4 - 4,0 μU/ml
- If TSH is not in normal range, fT3 and fT4must be determined fT3 2,3 - 4,5 pg/ml = 3,5 -7,0 pmol/l fT4 0,8 - 1,8 ng/dl = 8 - 18 ng/l = 10 - 23 pmol/l
- Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L)
- Electrolytes:
- Potassium: 3.5-5 mmol/L
- Sodium: 135-145 mmol/L
- Pancreatic:
- amylase, lipase ≤ 3 x ULN
- alkaline phosphatase (range to be assessed in context of oligometastatic disease)
- blood sugar < 200 mg/dL (11.1 mmol/L)
- Sexually active patients must use a condom to prevent them from fathering a child and to prevent delivery of study treatment via seminal fluid to their partner for at least 14 weeks after the last dose of [177Lu]Lu-PSMA-617.
- Tumor tissue of both prostate biopsy and radical prostatectomy specimen available for local histology review and reference pathology by Professor Henning Reis (Department of Pathology, University Hospital Frankfurt).
Who cannot join
- Distant metastasis (clinical stage M1) on conventional imaging. Oligometastatic patients on exclusively PSMA PET imaging will not be excluded. Patients with PSA values below 20ng/ml and no evidence of nodal disease are excluded.
- Prior treatment with androgen receptor antagonists. Treatment with GnRH analogs prior to ICF signature
- Bilateral orchiectomy
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
- Use of any investigational agent ≤4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
- Major surgery ≤4 weeks prior to randomization
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- Prior therapy with CTLA4 antibodies
- Previous treatment with any of the following within 6 months of randomization:
- Strontium-89, Samarium-153, Rhenium-186, Rhenium- 188, Radium-223,
- Previous PSMA-targeted radioligand therapy
- Any immunosuppressive therapy given within the past 30 days prior to study drug administration (excluding physiologic steroid hormone replacement and / or steroid therapy up to a maximum dose of 10 mg prednisone or equivalent per day)
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
- Lack of availability for clinical follow-up assessments.
- Other potential life-threatening malignancies within the past five years requiring treatment
- Serious cardiac, gastrointestinal, hepatic or pulmonary disease reducing life expectancy to less than five years
- Patients with serious intercurrent illness, requiring hospitalization.
- Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
- Patients carrying organ transplants and/or receiving continuous immunosuppressive medication (other than steroid therapy of up to 10 mg prednisone per day)
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
- Known hypersensitivity reaction to any of the components of study treatment
- Known alcohol or drug abuse
- Participation in another clinical study and use of any investigational or non-registered product (drug or vaccine) other than the study treatment within the 30 days before registration
- Significant disease or condition which, in the investigator's opinion, would exclude the patient from the study
- Legal incapacity or limited legal capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase I/II Study of Neoadjuvant Treatment With 177-Lutetium- PSMA-617 With or Without Ipilimumab in Subjects With Very High-risk Prostate Cancer Who Are Candidates for Radical Prostatectomy (NEPI Trial)
A randomized, open-label Phase I/II study of neoadjuvant treatment with [177Lu]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.
Read the detailed description
A randomized, open-label Phase I/II study of neoadjuvant treatment with [177Lu]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.
The study will be initiated by a safety cohort regarding the [177Lu]Lu- PSMA-617 dose including 6 to 12 patients, who will receive combination therapy with [177Lu]Lu-PSMA-617 and Ipilimumab. The Safety-Run-In-Phase follows a "none of three or one of six patients experienced intolerable events" approach per dose level. That is: The first 3 patients will receive 4 courses of ipilimumab (3 mg/kg) and 2 courses of 3.7 GBq [177Lu]Lu-PSMA-617. If no more than one of these patients develop grade 4 adverse reactions (ARs) without recovery within 3 weeks, another 3 patients will receive the same dosage. If no grade 4 AEs are observed in this second set of patients, we will enroll an additional 3 patients to increase the [177Lu]LuPSMA 617 dose to 7.4 GBq. If no more than one of those patients develop grade 4 ARs without recovery within 3 weeks back to grade ≤1 or to baseline values, another 3 patients will receive the same increased dosage. Provided that these patients do not develop grade 4 ARs, randomization of patients will be started. If the "none of three or one of six patients experienced intolerable events" approach per dose level is not passed the study will be terminated at this point.
46 patients with newly diagnosed very high-risk prostate cancer will be randomly assigned in a 1:1 ratio (Ipilimumab + [177Lu]Lu-PSMA- 617 vs. [177Lu]Lu-PSMA-617 alone) to receive 2 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 with or without 4 cycles of concomitant Ipilimumab 3mg/kg prior to prostatectomy. Radioligandtherapy will be given at 6 weeks intervals while ipilimumab will be given every 3 weeks. For application of ipilimumab and [177Lu]Lu-PSMA-617 within one cycle (week 1 and 7), [177Lu]Lu-PSMA-617 is administered on day 1 and ipilimumab on day 3. ADT will be applied to all patients during the neoadjuvant treatment phase.
- Conditions
- Very High Risk Prostate Carcinoma
- Being tested
- [177Lu]Lu-PSMA-617, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-PSMA-617Radiation
2 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 at 6 weeks intervals
IpilimumabDrug
4 cycles of Ipilimumab 3mg/kg at 3 weeks intervals
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Combination Therapy | Experimental | 4 cycles of Ipilimumab 3mg/kg + 2 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 Receives: Radiation: [177Lu]Lu-PSMA-617; Drug: Ipilimumab |
| Neoadjuvant Mono Therapy | Active comparator | 2 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 Receives: Radiation: [177Lu]Lu-PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to perform prostatectomy on time
Feasibility will be defined as the ability to perform prostatectomy in at least 75% of the Analysis population 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks. A treatment arm will be deemed not feasible in the actual study if >25% of patients of that arm required a delay of surgery >3 weeks.
Measured: During the intervention/procedure
Clinical activity: Proportion of participants in the full analysis set who achieve a pCR
The proportion of participants in the full analysis set who achieve a pathological complete response (pCR). The assessment of pCR will be reviewed by the central pathologist for all randomized patients with Radical Prostatectomy with pelvic lymphadenectomy conducted. The proportion of participants in the full analysis set who achieve a MRD. The assessment of MRD will be reviewed by the central pathologist for all randomized patients with Radical Prostatectomy with pelvic lymphadenectomy conducted.
Measured: After surgery
Secondary outcomes (2)
Safety Profile of neoadjuvant treatment before radical prostatectomy
Characterizing the safety profile of neoadjuvant treatment with Ipilimumab and [177Lu]Lu-PSMA-617 RLT before radical prostatectomy according to AEs and SAEs measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Start of neoadjuvant treatment up to 1 year after surgery
Safety Profile of neoadjuvant treatment before radical prostatectomy
Measures of PSA progression-free survival for up to 1 year after prostatectomy.
Measured: Start of neoadjuvant treatment up to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start25 Aug 2025
- Primary completion9 Mar 2026
- Study completion9 Mar 2026
Why it stopped: The clinical trial has been terminated due to the revocation of funding. Although one subject was enrolled, the participant withdrew prior to receiving any treatment. No trial-related procedures generating evaluable clinical data were performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very High Risk Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first patients are enrolled - without randomization - into the Safety Cohort to assess whether the treatment regime under investigation, i.e. Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq), is appropriately tolerated as per dose escalation algorithm. If it is established that Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq) is appropriately tolerated, patients will be randomized into the two arms of the Analysis Cohort: * Arm A: Ipilimumab + \[177Lu\]Lu-PSMA-617 RLT * Arm B: \[177Lu\]Lu-PSMA-617 RLT
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Accelerator Applications, Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388369
- Sponsor's protocol ID
- CA184-608
- Acronym
- NEPI
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Study of Neoadjuvant Treatment With 177-Lutetium- PSMA-617 With or Without Ipilimumab in Subjects With Very High-risk Prostate Cancer Who Are Candidates for Radical Prostatectomy (NEPI Trial)
- ClinicalTrials.gov ID
- NCT06388369
- Acronym / sponsor ID
- NEPI / CA184-608
- Conditions
- Very High Risk Prostate Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical trial has been terminated due to the revocation of funding. Although one subject was enrolled, the participant withdrew prior to receiving any treatment. No trial-related procedures generating evaluable clinical data were performed.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Advanced Accelerator Applications, Bristol-Myers Squibb
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, open-label Phase I/II study of neoadjuvant treatment with [177Lu]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.
Detailed description
A randomized, open-label Phase I/II study of neoadjuvant treatment with [177Lu]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.
The study will be initiated by a safety cohort regarding the [177Lu]Lu- PSMA-617 dose including 6 to 12 patients, who will receive combination therapy with [177Lu]Lu-PSMA-617 and Ipilimumab. The Safety-Run-In-Phase follows a "none of three or one of six patients experienced intolerable events" approach per dose level. That is: The first 3 patients will receive 4 courses of ipilimumab (3 mg/kg) and 2 courses of 3.7 GBq [177Lu]Lu-PSMA-617. If no more than one of these patients develop grade 4 adverse reactions (ARs) without recovery within 3 weeks, another 3 patients will receive the same dosage. If no grade 4 AEs are observed in this second set of patients, we will enroll an additional 3 patients to increase the [177Lu]LuPSMA 617 dose to 7.4 GBq. If no more than one of those patients develop grade 4 ARs without recovery within 3 weeks back to grade ≤1 or to baseline values, another 3 patients will receive the same increased dosage. Provided that these patients do not develop grade 4 ARs, randomization of patients will be started. If the "none of three or one of six patients experienced intolerable events" approach per dose level is not passed the study will be terminated at this point.
46 patients with newly diagnosed very high-risk prostate cancer will be randomly assigned in a 1:1 ratio (Ipilimumab + [177Lu]Lu-PSMA- 617 vs. [177Lu]Lu-PSMA-617 alone) to receive 2 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 with or without 4 cycles of concomitant Ipilimumab 3mg/kg prior to prostatectomy. Radioligandtherapy will be given at 6 weeks intervals while ipilimumab will be given every 3 weeks. For application of ipilimumab and [177Lu]Lu-PSMA-617 within one cycle (week 1 and 7), [177Lu]Lu-PSMA-617 is administered on day 1 and ipilimumab on day 3. ADT will be applied to all patients during the neoadjuvant treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first patients are enrolled - without randomization - into the Safety Cohort to assess whether the treatment regime under investigation, i.e. Ipilimumab (3mg/kg) + [177Lu]Lu-PSMA-617 RLT (7,4 GBq), is appropriately tolerated as per dose escalation algorithm. If it is established that Ipilimumab (3mg/kg) + [177Lu]Lu-PSMA-617 RLT (7,4 GBq) is appropriately tolerated, patients will be randomized into the two arms of the Analysis Cohort: * Arm A: Ipilimumab + [177Lu]Lu-PSMA-617 RLT * Arm B: [177Lu]Lu-PSMA-617 RLT
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Combination Therapy | Experimental | Radiation: [177Lu]Lu-PSMA-617, Drug: Ipilimumab4 cycles of Ipilimumab 3mg/kg + 2 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 |
| Neoadjuvant Mono Therapy | Active comparator | Radiation: [177Lu]Lu-PSMA-6172 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Must be ≥18 years of age
- Signed an informed consent form (ICF) indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study; participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Histologically confirmed adenocarcinoma of the prostate including following criteria: Very High-risk defined by a total Gleason-Score ≥4+4 (ISUP-GG 4+5) and clinical stage cT3 (digital rectal examination or imaging based) plus clinical nodal status cN+ or Serum-PSA level >20ng/ml
- Exclusion of metastases (M0) on conventional imaging and maximum oligometastatic status on PSMA PET imaging
- Treatment naïve patients
Key exclusion criteria (24 listed)
- Distant metastasis (clinical stage M1) on conventional imaging. Oligometastatic patients on exclusively PSMA PET imaging will not be excluded. Patients with PSA values below 20ng/ml and no evidence of nodal disease are excluded.
- Prior treatment with androgen receptor antagonists. Treatment with GnRH analogs prior to ICF signature
- Bilateral orchiectomy
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
- Use of any investigational agent ≤4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [177Lu]Lu-PSMA-6172 cycles of 7,4 GBq [177Lu]Lu-PSMA-617 at 6 weeks intervals | Radiation | Neoadjuvant Combination Therapy, Neoadjuvant Mono Therapy |
| Ipilimumab4 cycles of Ipilimumab 3mg/kg at 3 weeks intervals | Drug | Neoadjuvant Combination Therapy |
Primary outcome
Feasibility to perform prostatectomy on time
Time frame: During the intervention/procedure
Feasibility will be defined as the ability to perform prostatectomy in at least 75% of the Analysis population 85 days after start of neoadjuvant treatment with a maximum delay by 3 weeks. A treatment arm will be deemed not feasible in the actual study if >25% of patients of that arm required a delay of surgery >3 weeks.
Clinical activity: Proportion of participants in the full analysis set who achieve a pCR
Time frame: After surgery
The proportion of participants in the full analysis set who achieve a pathological complete response (pCR). The assessment of pCR will be reviewed by the central pathologist for all randomized patients with Radical Prostatectomy with pelvic lymphadenectomy conducted. The proportion of participants in the full analysis set who achieve a MRD. The assessment of MRD will be reviewed by the central pathologist for all randomized patients with Radical Prostatectomy with pelvic lymphadenectomy conducted.
2 secondary outcomes
Safety Profile of neoadjuvant treatment before radical prostatectomy
Time frame: Start of neoadjuvant treatment up to 1 year after surgery
Safety Profile of neoadjuvant treatment before radical prostatectomy
Time frame: Start of neoadjuvant treatment up to 1 year after surgery
Results and safety
The study was stopped early (reason given: The clinical trial has been terminated due to the revocation of funding. Although one subject was enrolled, the participant withdrew prior to receiving any treatment. No trial-related procedures generating evaluable clinical data were performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [177Lu]Lu-PSMA-617 and Ipilimumab in people with Very High Risk Prostate Carcinoma, run by University Hospital, Essen at 1 site in Germany.
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 32 inclusion and 24 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: stopped early, 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: The clinical trial has been terminated due to the revocation of funding. Although one subject was enrolled, the participant withdrew prior to receiving any treatment. No trial-related procedures generating evaluable clinical data were performed.). Results are not available in the source record.
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?
Feasibility to perform prostatectomy on time (time frame: During the intervention/procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.