What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as radioligand therapies like Lutetium [177Lu] vipivotide tetraxetan, often have side effects including nausea, fatigue, and hematologic toxicities like thrombocytopenia, lymphopenia, anemia, and leukopenia. These side effects are generally mild but can be more severe in some cases. Androgen receptor pathway inhibitors (ARPI), often used in combination with radioligand therapies, can cause side effects such as hot flashes, fatigue, hypertension, and an increased risk of fractures. It is important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including radiopharmaceuticals similar to Lutetium [177Lu] vipivotide tetraxetan. One notable approval is for Radium-223 dichloride (Xofigo), which targets bone metastases in castration-resistant prostate cancer (CRPC). Additionally, Lutetium Lu-177 dotatate has been approved for treating somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors, showcasing the potential of radioligand therapies. These approvals highlight the growing interest and validation of radiopharmaceuticals in cancer treatment.

What other types of research exist?

Promising alternatives to Lutetium [177Lu] vipivotide tetraxetan for prostate cancer treatment include: 1) Ra-223 (Radium-223) in combination with abiraterone or enzalutamide, which has shown improved survival in nonrandomized studies. 2) Beta-emitting radioisotopes like Strontium-89 and Samarium-153, which have been evaluated for bone metastases. 3) Investigational approaches such as multitargeted kinase inhibitors (e.g., regorafenib, cabozantinib, sorafenib) that target VEGFR and other kinases, showing some activity in advanced prostate cancer. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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Radioisotope Therapy

AAA617 Alone or Combined With ARPI 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

Summary

This trial is testing a new radioactive drug called AAA617, alone or with hormone-blocking medication, in men with a specific type of prostate cancer that hasn't spread and doesn't respond to usual treatments. The drug aims to kill cancer cells with radiation while the hormone blocker stops their growth.

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.

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.

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.

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.

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

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

Primary study objectives

PSA response

Secondary study objectives

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often target specific pathways or markers associated with cancer cells. Radioligand therapy, such as Lutetium [177Lu] vipivotide tetraxetan, targets the Prostate-Specific Membrane Antigen (PSMA) on cancer cells, delivering radiation directly to the tumor and minimizing damage to surrounding tissues. This targeted approach is crucial for patients as it can effectively reduce tumor size and progression with fewer side effects compared to conventional therapies. Other common treatments include Androgen Receptor Pathway Inhibitors (ARPIs) like enzalutamide, which block the effects of androgens that fuel cancer growth, and immunotherapies like sipuleucel-T, which stimulate the immune system to attack cancer cells. These therapies are significant as they offer personalized treatment options that can improve outcomes and quality of life for prostate cancer patients.

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,889 Previous Clinical Trials

4,201,884 Total Patients Enrolled

33 Trials studying Prostate Cancer

5,888 Patients Enrolled for Prostate Cancer

~80 spots leftby Oct 2027

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