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Radiation

SBRT + Pluvicto for Prostate Cancer (STARLiT Trial)

Phase 1 & 2

Waitlist Available

Led By Angela Y Jia, MD, PhD

Research Sponsored by Angela Y. Jia, MD PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be ≥ 18 years of age

ECOG performance status ≤ 1

Must not have

Contraindication to or inability to tolerate PSMA/PET

Prostate gland size >90 cc measured by ultrasound or MRI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using the drug Pluvicto instead of a standard therapy can reduce the risk of cancer coming back and maintain quality of life in patients with advanced prostate cancer. Participants will

Who is the study for?

This trial is for men with advanced local prostate cancer who haven't had hormone therapy yet. They should be fit for radiation treatment and willing to potentially delay hormone therapy. People can't join if they've already had certain treatments, have other cancers, or conditions that could interfere with the study.

What is being tested?

The trial tests Pluvicto (Lu-PSMA-617) combined with Stereotactic Body Radiation Therapy (SBRT). Participants get one dose of Pluvicto, followed by a series of five radiation treatments over two weeks, then possibly up to two more doses of Pluvicto at six-week intervals.

What are the potential side effects?

Pluvicto may cause dry mouth, nausea, fatigue, blood count changes and kidney issues. SBRT might lead to urinary problems like frequency and discomfort as well as bowel changes such as diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My prostate cancer has been confirmed through a biopsy.

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My scans show cancer has spread to my lymph nodes.

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My prostate cancer is advanced but hasn't spread to lymph nodes, with a high PSA level.

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My prostate cancer shows high activity on a PSMA PET scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo PSMA/PET scans due to health reasons.

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My prostate is larger than 90 cc as measured by imaging.

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I have had radiation therapy for head or neck cancer.

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I have received treatment for prostate cancer before.

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I have had radiation therapy in the pelvic area before.

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I have had blood cancer in the past.

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I have or have had Crohn's disease or ulcerative colitis.

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My cancer has spread to other parts of my body, as shown by scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Biochemical recurrence (BCR)

Change in Quality of life score as measured by EPIC-26

Change in Quality of life score as measured by FACT-RNT

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lu-PSMA-617 + SBRTExperimental Treatment2 Interventions

* 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

0 / 14Eligibility criteria met