RECRUITING

NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the baseline and following targeted radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC). 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.

Official Title

A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Quick Facts

Study Start:2024-07-29
Study Completion:2027-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06379217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have metastatic prostate cancer with neuroendocrine differentiation as determined by at least one of the following:
  2. 1. Histologically small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy confirmed by local laboratory.
  3. 2. Expression of NEPC markers (e.g., chromogranin or synaptophysin) in tumor tissue by IHC confirmed by local laboratory
  4. 3. Progression of visceral metastases in the absence of PSA progression
  5. 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
  6. 5. Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss)
  7. * 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
  8. * 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
  9. * Recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapy
  10. * Participant has adequate bone marrow and organ function (as assessed by central laboratory for eligibility)
  11. * ECOG status =\< 2
  1. * Previous treatment with any of the following within 6 months prior to Screening: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
  2. * Previous PSMA, SSTR2, or GRPR targeted radioligand therapy
  3. * Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy or investigational therapy
  4. * History of CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity
  5. * Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
  6. * History or current diagnosis of ECG abnormalities indicating significant risk of safety for study participants

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111
novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Stanford University
Palo Alto, California, 94304
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10017
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-29
Study Completion Date2027-06-23

Study Record Updates

Study Start Date2024-07-29
Study Completion Date2027-06-23

Terms related to this study

Keywords Provided by Researchers

  • [68Ga]Ga-PSMA-11
  • [177Lu]Lu-PSMA-617
  • [68Ga]Ga-DOTA-TATE
  • [177Lu]Lu-DOTA-TATE
  • [68Ga]Ga-NeoB
  • [177Lu]Lu-NeoB
  • Neuroendocrine prostate cancer (NEPC)
  • Metastatic Neuroendocrine Prostate Cancer (mNEPC)
  • Radioligand Imaging (RLI)
  • Radioligand Therapy (RLT)
  • Prostate-specific membrane antigen (PSMA)
  • Somatostatin Receptor 2 (SSTR2)
  • Gastrin Releasing Peptide Receptor (GRPR)
  • Phase 1

Additional Relevant MeSH Terms

  • Metastatic Neuroendocrine Prostate Cancer