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Radiopharmaceutical

Investigational Arm: lutetium (177Lu) vipivotide tetraxetan (AAA617) 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

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

PSMA-DC Trial 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.Check my eligibility

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.See study design

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.

PSMA-DC Trial 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.

PSMA-DC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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%

Weight decreased

33%

Diarrhoea

33%

Haemoptysis

33%

Thrombocytopenia

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%

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

PSMA-DC 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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,863 Previous Clinical Trials

4,198,639 Total Patients Enrolled

33 Trials studying Prostate Cancer

5,838 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for potential participants to enroll in this clinical trial?

"As outlined on clinicaltrials.gov, this research project is presently in the recruitment phase. The trial was first listed on March 12th, 2024 and most recently revised on April 17th of the same year."

Answered by AI

What is the current number of individuals who are being enrolled in this medical study?

"Indeed, information from clinicaltrials.gov confirms that this research endeavor is actively seeking candidates. The trial was publicly listed on March 12, 2024, and last revised on April 17, 2024. Recruitment aims to enroll a total of 450 individuals across eight designated locations."

Answered by AI

Are there numerous sites conducting this research study in North America?

"At the moment, recruitment is ongoing at 8 diverse locations such as Jerusalem, Geneve, and Luzern. Opting for a site in close proximity to your residence can help mitigate travel inconveniences during enrollment."

Answered by AI

Has the investigational treatment option using lutetium (177Lu) vipivotide tetraxetan (AAA617) received approval from the FDA?

"As part of a Phase 3 trial, the safety evaluation for the investigational arm involving lutetium (177Lu) vipivotide tetraxetan (AAA617) received a rating of 3 due to existing evidence backing its effectiveness and numerous data sets confirming its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

2024. "An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05939414.