NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
NCT ID: NCT06379217
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2024-07-29
2027-06-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study is planning to enroll approximately 20 participants in \[177Lu\]Lu-PSMA-617 treatment arm, approximately 3 participants in \[177Lu\]Lu-NeoB treatment arm, and approximately 13 participants in \[177Lu\]Lu-DOTA-TATE treatment arm.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
NCT05691465
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
NCT05983198
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
NCT05352178
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
NCT05053152
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
NCT03298087
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
At least six weeks after receiving the first cycle of RLT, participants must be scanned again with up to 3 RLIs but must be scanned, with at least with one RLI corresponding to the received RLT, which is recommended to be performed first. All post-baseline PET/CT scans should be performed using the same PET/CT imaging agent and same PET/CT camera, acquisition and reconstruction protocols as used for screening PET/CT for the participant.
The post-treatment follow-up period consists of a 42-days post EOT safety follow-up visit, efficacy, and survival follow-up until radiographic disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first.
The planned duration of treatment is up to 36 weeks for all treatment arms in this study, with treatment given every 6 weeks ±7 days. Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression, and/or at the discretion of the Investigator or the participant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
* \[177Lu\]Lu-PSMA-617 will be assigned to those with predominant PSMA expression
* \[177Lu\]Lu-DOTA-TATE will be assigned to those with predominant SSTR2 expression
* \[177Lu\]Lu-NeoB will be assigned to those with predominant GRPR expression
In complex cases the local Investigator has the authority to make decisions on the most appropriate RLT assignment.
If the selected RLT assignment is to a treatment arm that has reached its maximum enrollment, the patient will not be able to receive the selected RLT and will not join the treatment phase.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PSMA-predominant NEPC
[68Ga]Ga-PSMA-11
\[68Ga\]Ga-PSMA-11 will be administered as a single intravenous dose of approximately 150 MBq (4 mCi) to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. Administered dose should not be lower than 111 MBq (3 mCi) or higher than 259 MBq (7 mCi)
[68Ga]GA-DOTA-TATE
\[68Ga\]Ga-DOTA-TATE will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 100-200MBq (2.7-5.4 mCi)
[68Ga]Ga-NeoB
\[68Ga\]Ga-NeoB will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 150-250 MBq (4.1-6.8 mCi).
[177Lu]Lu-PSMA-617
\[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for 6 cycles.
Gonadotropin-releasing hormone (GnRH) analogues
Anatomical Therapeutic Chemical \[ATC\] code L02AE
GnRH antagonists
abarelix, degarelix, or relugolix
SSTR2-predominant NEPC
[68Ga]Ga-PSMA-11
\[68Ga\]Ga-PSMA-11 will be administered as a single intravenous dose of approximately 150 MBq (4 mCi) to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. Administered dose should not be lower than 111 MBq (3 mCi) or higher than 259 MBq (7 mCi)
[68Ga]GA-DOTA-TATE
\[68Ga\]Ga-DOTA-TATE will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 100-200MBq (2.7-5.4 mCi)
[68Ga]Ga-NeoB
\[68Ga\]Ga-NeoB will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 150-250 MBq (4.1-6.8 mCi).
[177Lu]Lu-DOTA-TATE
\[177Lu\]Lu-DOTA-TATE will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%) every 6 weeks for 6 cycles.
L-Lysine HCl-L-Arginine HCl, 2.5 %,
sterile solution for infusion Lysine HCl-Arginine HCl, 2.5 % (1L)
Gonadotropin-releasing hormone (GnRH) analogues
Anatomical Therapeutic Chemical \[ATC\] code L02AE
GnRH antagonists
abarelix, degarelix, or relugolix
Antiemetics & antinauseants
ATC code A04A
Metoclopramide
ATC code A03FA01
GRPR-predominant NEPC
[68Ga]Ga-PSMA-11
\[68Ga\]Ga-PSMA-11 will be administered as a single intravenous dose of approximately 150 MBq (4 mCi) to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. Administered dose should not be lower than 111 MBq (3 mCi) or higher than 259 MBq (7 mCi)
[68Ga]GA-DOTA-TATE
\[68Ga\]Ga-DOTA-TATE will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 100-200MBq (2.7-5.4 mCi)
[68Ga]Ga-NeoB
\[68Ga\]Ga-NeoB will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 150-250 MBq (4.1-6.8 mCi).
[177Lu]Lu-NeoB
\[177Lu\]Lu-NeoB will be administered as an intravenous infusion at a dose of 9.25 GBq (250mCi) every 6 weeks for 6 cycles
Gonadotropin-releasing hormone (GnRH) analogues
Anatomical Therapeutic Chemical \[ATC\] code L02AE
GnRH antagonists
abarelix, degarelix, or relugolix
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[68Ga]Ga-PSMA-11
\[68Ga\]Ga-PSMA-11 will be administered as a single intravenous dose of approximately 150 MBq (4 mCi) to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. Administered dose should not be lower than 111 MBq (3 mCi) or higher than 259 MBq (7 mCi)
[68Ga]GA-DOTA-TATE
\[68Ga\]Ga-DOTA-TATE will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 100-200MBq (2.7-5.4 mCi)
[68Ga]Ga-NeoB
\[68Ga\]Ga-NeoB will be administered as a single intravenous dose to be administered during baseline imaging and at any time ≥ 6 weeks after first RLT dose. Sites should consider doing PET/CT imaging with RLT corresponding RLI as the first of three PET/CT scans. within a range of 150-250 MBq (4.1-6.8 mCi).
[177Lu]Lu-PSMA-617
\[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for 6 cycles.
[177Lu]Lu-DOTA-TATE
\[177Lu\]Lu-DOTA-TATE will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%) every 6 weeks for 6 cycles.
[177Lu]Lu-NeoB
\[177Lu\]Lu-NeoB will be administered as an intravenous infusion at a dose of 9.25 GBq (250mCi) every 6 weeks for 6 cycles
L-Lysine HCl-L-Arginine HCl, 2.5 %,
sterile solution for infusion Lysine HCl-Arginine HCl, 2.5 % (1L)
Gonadotropin-releasing hormone (GnRH) analogues
Anatomical Therapeutic Chemical \[ATC\] code L02AE
GnRH antagonists
abarelix, degarelix, or relugolix
Antiemetics & antinauseants
ATC code A04A
Metoclopramide
ATC code A03FA01
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Histologically small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy confirmed by local laboratory.
2. Expression of NEPC markers (e.g., chromogranin or synaptophysin) in tumor tissue by IHC confirmed by local laboratory
3. Progression of visceral metastases in the absence of PSA progression
4. Serum chromogranin A \> 5x normal limit, or neuron-specific enolase \> 2x normal limit with control for proton-pump inhibitors (PPI) drugs among concomitant treatment
5. Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss)
* PSMA and/or SSTR2 and/or GRPR PET-positive participants, with at least one measurable lesion per RECIST 1.1 with moderate target expression in at least one of the 3 PET/CT scans per BICR assessment
* Castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7 nmol/L) for participants with adenocarcinoma component or stable testosterone level for participants with pure neuroendocrine carcinoma
* Recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapy
* Participant has adequate bone marrow and organ function (as assessed by central laboratory for eligibility)
* ECOG status =\< 2
Exclusion Criteria
* Previous PSMA, SSTR2, or GRPR targeted radioligand therapy
* Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy or investigational therapy
* History of CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity
* Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for study participants
18 Years
100 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Palo Alto, California, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Rostock, , Germany
Novartis Investigative Site
Meldola, FC, Italy
Novartis Investigative Site
Reggio Emilia, RE, Italy
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Sutton, Surrey, United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-505655-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAAA617H12101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.