RECRUITING

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

Conditions

Malignant Neoplasm of Prostate Locally Advanced Prostate Cancer Prostate cancer

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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 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.

Official Title

STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial

Quick Facts

Study Start:2025-05-06

Study Completion:2026-09-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06574880

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

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * White blood cell (WBC) \> 3000 / mL * Absolute neutrophil count ≥ 1,500 / mcL * Platelets ≥ 100,000 / mcL * Creatinine ≤ 1.5x ULN * Estimated glomerular filtration rate (eGFR)\* \> 50 mL/min * Total bilirubin\\ \< 2× ULN * Albumin \> 3 g/dL * Aspartate aminotransferase (AST) \< 3× ULN * \based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Participants with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only participants with non-obstructive pathology will be included in the study. \\ Total bilirubin ≤ 2x ULN (except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted) * International Prostate Symptoms Score (IPSS) ≤ 15. * Medically fit for treatment and agreeable to follow-up. * Ability to understand and the willingness to sign a written informed consent. * Participants with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 14 weeks from receiving the last dose of Lu-PSMA-617. Participants must also not donate sperm for 14 weeks from receiving the last dose of Lu-PSMA-617.	* 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 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, chemotherapy, immunotherapy, 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 hematologic malignancies, including myelodysplastic syndrome or 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.

Inclusion Criteria

Exclusion Criteria

* 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
* White blood cell (WBC) \> 3000 / mL
* Absolute neutrophil count ≥ 1,500 / mcL
* Platelets ≥ 100,000 / mcL
* Creatinine ≤ 1.5x ULN
* Estimated glomerular filtration rate (eGFR)\* \> 50 mL/min
* Total bilirubin\*\* \< 2× ULN
* Albumin \> 3 g/dL
* Aspartate aminotransferase (AST) \< 3× ULN
* \*based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Participants with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only participants with non-obstructive pathology will be included in the study.
* \*\* Total bilirubin ≤ 2x ULN (except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted)
* International Prostate Symptoms Score (IPSS) ≤ 15.
* Medically fit for treatment and agreeable to follow-up.
* Ability to understand and the willingness to sign a written informed consent.
* Participants with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 14 weeks from receiving the last dose of Lu-PSMA-617. Participants must also not donate sperm for 14 weeks from receiving the last dose of Lu-PSMA-617.

* 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 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, chemotherapy, immunotherapy, 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 hematologic malignancies, including myelodysplastic syndrome or 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.

Contacts and Locations

Study Contact

Angela Y Jia, MD, PhD

CONTACT

216-844-3262

Angela.Jia@UHhospitals.org

Principal Investigator

Angela Y Jia, MD, PhD

PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Daniel E Spratt, MD

STUDY_CHAIR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Locations (Sites)

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

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Angela Y. Jia, MD PhD

Angela Y Jia, MD, PhD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Daniel E Spratt, MD, STUDY_CHAIR, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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 Date2025-05-06

Study Completion Date2026-09-11

Study Record Updates

Study Start Date2025-05-06

Study Completion Date2026-09-11

Terms related to this study

Keywords Provided by Researchers

Prostate cancer

Additional Relevant MeSH Terms

Malignant Neoplasm of Prostate
Locally Advanced Prostate Cancer