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Radiopharmaceutical
Long-Term Safety of AAA617 for Prostate Cancer
Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every visit up to 10 years after 1st dose of aaa617 received in parent treatment study
Awards & highlights
Study Summary
This trial is studying the long-term effects of a prostate cancer drug (AAA617) on adults from interventional studies.
Who is the study for?
This trial is for adult men with prostate cancer who have previously received at least one dose of AAA617 in a Novartis-sponsored clinical trial. Participants must consent to the study and agree to use condoms during intercourse for up to 14 weeks after their last treatment.Check my eligibility
What is being tested?
The study aims to understand the long-term safety of Lutetium (177Lu) Vipivotide Tetraxetan, also known as AAA617, in treating prostate cancer. It will track any serious side effects that occur over time in patients who've used this drug.See study design
What are the potential side effects?
While specific side effects are not listed here, the study focuses on identifying long-term risks and serious adverse reactions related to AAA617 treatment in prostate cancer patients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every visit up to 10 years after 1st dose of aaa617 received in parent treatment study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every visit up to 10 years after 1st dose of aaa617 received in parent treatment study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and proportion of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Incidence and proportion of death
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Participants will be followed until death, lost to follow-up, or up to 10 years from first dose of AAA617, whichever occurs first.
There will be no study treatment administered to participants while participating in this study.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,197,609 Total Patients Enrolled
32 Trials studying Prostate Cancer
5,138 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received AAA617 in a Novartis trial for prostate cancer and met all its requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any known risks associated with the use of AAA617?
"The Power team gave AAA617 a safety rating of 3, as it is in Phase 4 and has been approved for use."
Answered by AI
Is this clinical trial presently accepting participants?
"This clinical trial is currently onboarding patients, as seen on the information available through clinicaltrials.gov. The original post was published on July 31st 2023 and has been updated most recently August 3rd 2023."
Answered by AI
How many participants are being inducted into this research project?
"Affirmative. According to the information on clinicaltrials.gov, this research project is currently searching for volunteers and was first posted on July 31st 2023, with its most recent update coming August 3rd 2023. The trial requires 700 participants at one site specifically."
Answered by AI
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