Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617

NCT06972628 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Super-Lu-177
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan. Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap. The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose. The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population. This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.

Conditions

Metastatic Castration-Resistant Prostate Cancer; Prostate Cancer Patients With Bone Metastasis; Prostate Cancer (CRPC); Prostate Cancer; Prostate Cancer Metastatic

Keywords

Metastatic Castration-Resistant Prostate Cancer (mCRPC); super scan bone scan; Prostate Cancer patients with bone metastasis; prostate cancer (CRPC); Prostate cancer; Prostate cancer metastatic

Outcome Measures

Primary Outcomes (2)

• Radiographic progression-free survival

  rPFS: Defined as the time from enrollment to radiographic disease progression, based on Prostate Cancer Working Group 3 (PCWG3) Guidelines (Scher et al., 2016), or death from any cause.

  From date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 months.

• Overall Survival

  OS: Defined as the time from enrollment to death from any cause.

  From date of enrollment until the date of death from any cause, assessed up to 24 months.

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Drug: Administering Lutetium-177-PSMA-617 (PLUVICTO)

Interventions

Administering Lutetium-177-PSMA-617 (PLUVICTO) DRUG

The study begins with a first cohort of three participants, each receiving a dose of 100 millicuries (mCi). After administration, participants are monitored for any dose-limiting toxicities (DLTs) during a predefined observation window. If fewer than two participants experience a DLT in a given cohort, the dose will be escalated for the next group. The dose escalation schedule is structured as follows: the second cohort receives 130 mCi (a 30% increase), the third cohort receives 162.5 mCi (a 25% increase), and the fourth cohort receives 200 mCi, a dose that is already FDA-approved and clinically accepted for mCRPC. This stepwise escalation continues until the 200 mCi dose is reached, or until two or more DLTs are observed in any cohort. If that occurs, escalation stops immediately, and the maximum tolerated dose is considered to be the previous lower dose. This becomes the optimal tolerated dose (OTD). After identifying the OTD, additional participants will be enrolled for treatment.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and sign an informed consent form (ICF).
• Willingness and ability to comply with study requirements.
• Age ≥18 years.
• Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Hemoglobin ≥9.0 g/dL.
• Platelet count ≥90 × 10⁹/L.
• White blood cell count ≥2.0 × 10⁹/L, absolute neutrophil count (ANC) \>1.5 × 10⁹/L.
• o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).
• Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN).
• Histological, pathological, or cytological confirmation of prostate cancer.
• Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
• Castrate-level serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
• Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).

You may not qualify if:

• Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.
• Prior PSMA-targeted radioligand therapy.
• Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
• Known hypersensitivity to PLUVICTO or its components.
• Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
• Renal impairment (estimated glomerular filtration rate \<60 mL/min), hemoglobin \<9 g/dL, ANC \<1.5 × 10⁹/L, or platelets \< 90 × 10⁹/L.
• History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
• Symptomatic or impending spinal cord compression.
• Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.
• Major surgery within 30 days prior to enrollment.
• Plans to conceive or father a child during treatment and up to six months post-treatment.

Sponsors & Collaborators

• Ebrahim S Delpassand: lead

Study Sites (1)

Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, 77042, United States

RECRUITING

Related Publications (10)

• Hartrampf PE, Weinzierl FX, Buck AK, Rowe SP, Higuchi T, Seitz AK, Kubler H, Schirbel A, Essler M, Bundschuh RA, Werner RA. Matched-pair analysis of [177Lu]Lu-PSMA I&T and [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2022 Jul;49(9):3269-3276. doi: 10.1007/s00259-022-05744-6. Epub 2022 Mar 4.

  PMID: 35243517 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Banerjee SR, Pullambhatla M, Byun Y, Nimmagadda S, Green G, Fox JJ, Horti A, Mease RC, Pomper MG. 68Ga-labeled inhibitors of prostate-specific membrane antigen (PSMA) for imaging prostate cancer. J Med Chem. 2010 Jul 22;53(14):5333-41. doi: 10.1021/jm100623e.

  PMID: 20568777 BACKGROUND

• Hope TA, Abbott A, Colucci K, Bushnell DL, Gardner L, Graham WS, Lindsay S, Metz DC, Pryma DA, Stabin MG, Strosberg JR. NANETS/SNMMI Procedure Standard for Somatostatin Receptor-Based Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE. J Nucl Med. 2019 Jul;60(7):937-943. doi: 10.2967/jnumed.118.230607.

  PMID: 31263080 BACKGROUND

• Ahmadzadehfar H, Eppard E, Kurpig S, Fimmers R, Yordanova A, Schlenkhoff CD, Gartner F, Rogenhofer S, Essler M. Therapeutic response and side effects of repeated radioligand therapy with 177Lu-PSMA-DKFZ-617 of castrate-resistant metastatic prostate cancer. Oncotarget. 2016 Mar 15;7(11):12477-88. doi: 10.18632/oncotarget.7245.

  PMID: 26871285 BACKGROUND

• Messiou C, Cook G, deSouza NM. Imaging metastatic bone disease from carcinoma of the prostate. Br J Cancer. 2009 Oct 20;101(8):1225-32. doi: 10.1038/sj.bjc.6605334. Epub 2009 Sep 29.

  PMID: 19789531 BACKGROUND

• Caglar M, Tuncel M, Yildiz E, Karabulut E. Bone scintigraphy as a gatekeeper for the detection of bone metastases in patients with prostate cancer: comparison with Ga-68 PSMA PET/CT. Ann Nucl Med. 2020 Dec;34(12):932-941. doi: 10.1007/s12149-020-01529-9. Epub 2020 Sep 25.

  PMID: 32975741 BACKGROUND

• Askari E, Shakeri S, Roustaei H, Fotouhi M, Sadeghi R, Harsini S, Vali R. Superscan Pattern on Bone Scintigraphy: A Comprehensive Review. Diagnostics (Basel). 2024 Oct 6;14(19):2229. doi: 10.3390/diagnostics14192229.

  PMID: 39410633 BACKGROUND

• Manov JJ, Roth PJ, Kuker R. Clinical Pearls: Etiologies of Superscan Appearance on Fluorine-18-Fludeoxyglucose Positron Emission Tomography-Computed Tomography. Indian J Nucl Med. 2017 Oct-Dec;32(4):259-265. doi: 10.4103/ijnm.IJNM_56_17.

  PMID: 29142340 BACKGROUND

• Manohar PR, Rather TA, Khan SH, Malik D. Skeletal Metastases Presenting as Superscan on Technetium 99m Methylene Diphosphonate Whole Body Bone Scintigraphy in Different Type of Cancers: A 5-Year Retro-prospective Study. World J Nucl Med. 2017 Jan-Mar;16(1):39-44. doi: 10.4103/1450-1147.181153.

  PMID: 28217018 BACKGROUND

Related Links

• Data on file. VISION \[PSMA-617-01\] study. Novartis Pharmaceuticals Corp; 2021.
• American Cancer Society . Cancer Facts and Statistics: American Cancer Society. 2015

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Pluvicto

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine

  Excel Diagnostics & Nuclear Oncology Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Cork Therapy Coordinator

CONTACT

713-781-6200; scork@exceldiagnostics.com

Nereyda Sauceda, Therapy Coordinator

CONTACT

713-781-6200; nsauceda@exceldiagnostics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman & Medical Director, Excel Diagnostics & Nuclear Oncology Center

Model Details: This study uses an FDA-approved drug (PLUVICTO). Therefore, it is not subject to phase categorization.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 15, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)