Recruiting

STARLiTLutetium PSMA and Stereotactic Radiotherapy in Advanced Prostate Cancer

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What is being tested

Lu-PSMA-617

+ 5-fraction Stereotactic Body Radiation Therapy (SBRT)

DrugRadiation
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorAngela Y. Jia, MD PhD
Study ContactAngela Y Jia, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 13, 2025

Actual date on which the first participant was enrolled.

Prostate cancer is a common and serious illness affecting many men around the world. Traditional treatments often involve a combination of radiation therapy and long-term hormone therapy, which can lead to significant side effects and impact on quality of life. This study explores a new approach by using a drug called Pluvicto in combination with targeted radiation therapy to see if it can effectively treat prostate cancer while reducing the side effects commonly associated with hormone therapy. The goal is to improve the quality of life for patients and reduce the chances of cancer returning. Participants in this study will receive a combination of a drug called Lu-PSMA-617 and a special type of radiation therapy that targets the prostate and nearby lymph nodes. The study is designed to assess the safety and effectiveness of this new treatment approach. Researchers will monitor how well the treatment works in preventing cancer from coming back and whether it helps avoid the side effects linked to traditional hormone therapies. The focus is on finding a treatment that is both effective and easier for patients to continue with, improving overall treatment compliance.

Official TitleSTARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial
NCT06574880
Principal SponsorAngela Y. Jia, MD PhD
Study ContactAngela Y Jia, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

10 inclusion criteria required to participate
Histologic confirmation of prostate adenocarcinoma of the prostate
Participant must be ≥ 18 years of age.
Ability to understand and the willingness to sign a written informed consent.
ECOG performance status ≤ 1
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16 exclusion criteria prevent from participating
Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and radiopharmaceuticals.
History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer.
Prostate gland size \>90 cc measured by CT, ultrasound, or MRI
Enrollment concurrently in another investigational drug study within 6 months of registration.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Cleveland, United StatesOpen University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center in Google Maps
Recruiting
One Study Center