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Radioisotope Therapy

Arm A for Prostate Cancer (PSMACare Trial)

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Key

Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until psa nadir value of =< 0.2 ng/ml that is confirmed by a second (the next) psa measurement >= 4 weeks later, up to 5 years

Awards & highlights

PSMACare Trial Summary

This trial aims to test the effectiveness and safety of AAA617, a treatment for prostate cancer, both on its own and when combined with another medication called Androgen Receptor Pathway Inhibitors (

Who is the study for?

This trial is for adults over 18 with advanced prostate cancer that hasn't spread according to scans, but shows up on a special PSMA PET scan. They must be on hormone therapy or have had surgery to lower testosterone and have a rising PSA level indicating the cancer is growing despite treatment.Check my eligibility

What is being tested?

The study tests AAA617 alone and combined with ARPI drugs in men whose prostate cancer can be seen on a PSMA PET scan but not regular imaging. It checks if these treatments can control the cancer without it appearing elsewhere in the body.See study design

What are the potential side effects?

Possible side effects include tiredness, nausea, changes in blood counts leading to increased infection risk or bleeding, kidney problems, and reactions at the drug injection site.

PSMACare Trial Eligibility Criteria

Inclusion Criteria

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

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It seems like the criterion "Key" might be incomplete. Can you please provide more context or details so that I can accurately summarize it for you?

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My testosterone levels are very low due to treatment or surgery.

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My bone marrow is functioning well.

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My liver, kidneys, and bone marrow are functioning well.

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My scans show PSMA-positive disease according to specific PET scan criteria.

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My PSA levels are high and my scans show PSMA-positive but no distant cancer spread.

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My prostate cancer is resistant to hormone therapy, shown by rising PSA levels.

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I have prostate cancer without certain rare features and am expected to live at least another year.

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My testosterone levels are very low due to treatment or surgery.

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My prostate cancer diagnosis was confirmed through lab tests.

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I am currently on hormone therapy for cancer or have had both testicles removed.

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I am currently on hormone therapy for cancer or have had both testicles removed.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

PSMACare Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until psa nadir value of =< 0.2 ng/ml that is confirmed by a second (the next) psa measurement >= 4 weeks later, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until psa nadir value of =< 0.2 ng/ml that is confirmed by a second (the next) psa measurement >= 4 weeks later, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until psa nadir value of =< 0.2 ng/ml that is confirmed by a second (the next) psa measurement >= 4 weeks later, up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

PSA response

Secondary outcome measures

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

Functional Assessment of Cancer Therapy - Prostate (FACT-P)

Functional Assessment of Cancer Therapy - Radiotherapies (FACT-RNT) Questionnaire

+13 more

PSMACare Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment6 Interventions

Participants will receive 7.4 GBq (+/- 10%) of AAA617 (Lutetium [177Lu] vipivotide tetraxetan) once every 6 weeks for 6 cycles. In addition of SOC (ADT plus choice of ARPI as per physician's decision), Best supportive care is allowed.

Group II: Arm AExperimental Treatment5 Interventions

Participants will receive 7.4 GBq (+/- 10%) of AAA617 (Lutetium [177Lu] vipivotide tetraxetan) once every 6 weeks for 6 cycles. ADT must be ongoing; Best supportive care is allowed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADT

2009

Completed Phase 3

~5120

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,189 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 any ongoing opportunities for patients to participate in this medical study?

"Indeed, according to the information available on clinicaltrials.gov, this trial is currently seeking eligible participants. The trial was initially posted on January 3rd, 2024 and its most recent update occurred on January 29th, 2024."

Answered by AI

What is the level of safety associated with Arm A in relation to individuals?

"Based on our evaluation at Power, Arm A's safety is rated as a 2 on a scale from 1 to 3. This rating reflects the fact that while there is some data supporting its safety in this Phase 2 trial, no evidence has been found yet regarding its efficacy."

Answered by AI

How many individuals are currently participating in this research trial?

"Indeed, the information available on clinicaltrials.gov confirms that this ongoing medical trial is actively enrolling participants. The initial posting of the trial was on January 3rd, 2024 and it has been recently updated as of January 29th, 2024. To complete the study successfully, a total of 120 patients are sought from two designated locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

2024. "A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05849298.

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