STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

NCT06574880 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CASE7824
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.

Conditions

Malignant Neoplasm of Prostate; Locally Advanced Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (2)

• Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-617

  The Phase I goal is to determine the maximally tolerated dose (MTD) of Lu-PSMA-617 when administered with prostate SBRT treatment. The MTD will be captured by analyzing the incidence of dose limiting toxicities occurring within the four weeks after the last dose of treatment.

  4 weeks after final dose of treatment (treatment expected to last up to six months)

• Phase II: Androgen deprivation therapy (ADT)-free survival

  The Phase II goal is to determine the 3-year rate of ADT-free survival.

  3 years post treatment

Secondary Outcomes (14)

• PSA Progression Free Survival

  2 years post treatment

• Overall Survival (OS)

  5 years post treatment

• Prostate Cancer-specific Survival (PCSM)

  5 years post treatment

• Cumulative incidence of distant metastases

  5 years post treatment

• Time to any salvage therapy

  5 years post treatment

Study Arms (1)

Lu-PSMA-617 + SBRT

EXPERIMENTAL

* Lu-PSMA-617: 7.4GBq intravenous infusion once with cycle 1, followed by 7.4GBq cycle 2 that is delivered 6 weeks after SBRT , and potentially 7.4GBq cycle #3 delivered 6 weeks after cycle #2 pending dose escalation * Radiation therapy: 5 fractions to prostate and elective nodal irradiation, SBRT, delivered 6 weeks after cycle 1 of 177Lu-PSMA-617

Drug: Lu-PSMA-617; Radiation: 5-fraction Stereotactic Body Radiation Therapy (SBRT)

Interventions

Lu-PSMA-617 DRUG

Lu-PSMA will be administered at a fixed dose of 7.4GBq per cycle, on a dose escalation schedule: * Level 0: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT. * Level 1 (Starting Dose Level): Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2. * Level 2: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2, followed 6 weeks later by cycle 3.

Also known as: Pluvicto

Lu-PSMA-617 + SBRT

5-fraction Stereotactic Body Radiation Therapy (SBRT) RADIATION

Prostate and nodal SBRT will begin at the completion of cycle 1 (6 weeks after the first Lu-PSMA-617 infusion, ± 4 weeks).

Also known as: SBRT

Lu-PSMA-617 + SBRT

Eligibility Criteria

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

You may qualify if:

• Participant must be ≥ 18 years of age.
• ECOG performance status ≤ 1
• Histologic confirmation of prostate adenocarcinoma of the prostate
• PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10.
• PSMA PET/CT must be obtained within 4 months.
• Need ≥ 1 criteria:
• Node positive disease on PSMA PET/CT or conventional imaging, as defined by having any of the following:
• Pelvic nodal disease (cN1) as defined by LN stations that commence at the bifurcation of the common iliac vessels
• Regional nodal disease (M1a) as defined by LN stations that commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
• In the absence of nodal metastasis, must have ≥ 2 of the following
• i. cT3a or cT3b by conventional imaging (MRI) or PSMA PET/CT
• ii. Grade group ≥ 4
• iii. PSA ≥ 40 ng/mL
• Adequate organ and marrow function to receive treatment:
• Hemoglobin \> 10 g/dL

You may not qualify if:

• Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation. Negative PSMA PET/CT is an acceptable substitute to conventional staging.
• Prostate gland size \>90 cc measured by CT, ultrasound, or MRI
• Prior head and neck radiation therapy.
• Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).
• Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
• Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and radiopharmaceuticals.
• History of prior pelvic radiation therapy.
• Enrollment concurrently in another investigational drug study within 6 months of registration.
• History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer.
• History of prior myelodysplastic syndrome or acute leukemia.
• History of or active Crohn's disease or ulcerative colitis.
• Contraindication to or inability to tolerate PSMA/PET.
• Any condition that in the opinion of the investigator would preclude participation in this study.
• Inability to adhere to radiation safety measures in hospital or at home
• Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other

Sponsors & Collaborators

• Angela Y. Jia, MD PhD: lead

Study Sites (1)

University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

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

• Angela Y Jia, MD, PhD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Daniel E Spratt, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Central Study Contacts

Angela Y Jia, MD, PhD

CONTACT

216-844-3262; Angela.Jia@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: May 13, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Compiled and analyzed participant data will be published upon study completion. Publisher may request Protocol and Statistical Analysis Plan.
• Access Criteria: To be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)