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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

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 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

Side effects data

From 2011 Phase 1 & 2 trial • 26 Patients • NCT00142415
67%
Leukopenia
67%
Dizziness
67%
Fatigue
67%
Decreased appetite
33%
Diarrhoea
33%
Thrombocytopenia
33%
Weight decreased
33%
Haemoptysis
33%
Nausea
33%
Upper respiratory tract inflammation
33%
Vomiting
33%
Pain in extremity
33%
Tachycardia
33%
Constipation
33%
Anaemia
33%
Cough
33%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250
Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250
Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250
Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250
Total
Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250
Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250

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.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,554 Total Patients Enrolled
33 Trials studying Prostate Cancer
5,888 Patients Enrolled for Prostate Cancer
~300 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
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