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Radiopharmaceutical

Lutetium (177Lu) Vipivotide Tetraxetan for Prostate Cancer (PSMA-DC Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

At least 1 PSMA-positive lesion should be a distant metastasis per AJCC8 classification at screening

Non-castration testosterone level >100 ng/dL at screening

Must not have

Diagnosed at screening with other malignancies that are expected to alter life expectancy or may interfere with disease assessment

Participants with de novo OMPC at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until date of first documented psa progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to test the effectiveness and safety of a drug called lutetium (177Lu) vipivotide tetraxetan (AAA617) in patients with prostate cancer that has spread

Who is the study for?

This trial is for adults over 18 with oligometastatic prostate cancer (OMPC) who've had prior treatment to their primary tumor. They should have a life expectancy of at least 24 months, an ECOG performance status of 0 or 1, and no more than five PSMA-positive metastatic lesions. Participants must not be eligible if they show clear signs of metastasis on conventional imaging that aren't related to the tumor.

What is being tested?

The study tests Lutetium (177Lu) vipivotide tetraxetan (AAA617), aiming to control recurrent tumors in early-stage prostate cancer patients and delay the need for androgen deprivation therapy. It compares this new treatment's effectiveness and safety against simply observing the progression without intervention.

What are the potential side effects?

While specific side effects are not listed here, treatments like AAA617 may cause fatigue, nausea, pain at injection sites, allergic reactions, blood count changes or radiation-related side effects due to its radioactive nature.

Eligibility Criteria

Inclusion Criteria

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

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I have at least one cancer spread that is PSMA-positive.

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My testosterone level is above 100 ng/dL.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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I have prostate cancer with 5 or fewer PSMA-positive spots found on a special scan.

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My prostate cancer returned after surgery or radiation treatment.

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All my cancer spread can be targeted with focused radiation.

Exclusion Criteria

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

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I have another cancer diagnosis that could affect my life expectancy or interfere with this cancer's assessment.

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I was diagnosed with prostate cancer when it was first found.

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I have severe bladder control problems that can't be managed.

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I have undergone hormone therapy for cancer, including surgery to remove my testicles.

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I stopped hormone therapy because my cancer got worse.

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I have not had radiation therapy in the last 28 days.

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I am not currently on any cancer treatments like chemotherapy or immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until date of first documented psa progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until date of first documented psa progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until date of first documented psa progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)

Secondary study objectives

24-month prostate-specific antigen (PSA) progression free survival (PFS)

Brief Pain Inventory - Short Form (BPI-SF) Questionnaire

Dose modifications and intensity for AAA617

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational Arm: lutetium (177Lu) vipivotide tetraxetan (AAA617)Experimental Treatment1 Intervention

All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by a dose of 7.4 GBq (200 mCi) +/- 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for a planned 4 cycles.

Group II: Control arm: observation (watchful waiting)Active Control1 Intervention

All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by observation only.

0 / 13Eligibility criteria met