Recruiting

PSMA-DCLutetium (177Lu) Vipivotide Tetraxetan for PSMA Positive Oligometastatic Prostate Cancer

Study Aim

This phase 3 study aims to evaluate how effective Lutetium (177Lu) Vipivotide Tetraxetan is in prolonging the time without metastasis for individuals with PSMA positive oligometastatic prostate cancer.

What is being tested

AAA617

Drug

Who is being recruted

From 18 to 100 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: March 2024

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals

Study ContactNovartis PharmaceuticalsMore contacts

Last updated: March 24, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 12, 2024

Actual date on which the first participant was enrolled.

This study aims to compare the effects of a new treatment, called Lutetium (177Lu) Vipivotide Tetraxetan (AAA617), against just monitoring the condition in men with a specific type of prostate cancer that has spread to a few other areas (oligometastatic prostate cancer). The cancer must show positive results on a test called PSMA, which helps doctors see where the cancer has spread. The goal is to see if this new treatment can delay the cancer's return or the need for more aggressive treatments. This research is important because finding a way to delay cancer progression could improve life quality and outcomes for men with this condition. Participants in the study will first undergo scans to assess their cancer, including a special PET/CT scan that uses specific tracers like gallium-68 or piflufolastat, depending on availability in their country. Afterward, they will receive a targeted radiation treatment called Stereotactic Body Radiation Therapy (SBRT) to all detected cancer lesions. Those in the treatment group will then receive up to four cycles of AAA617, while the control group will only be observed after SBRT. The study will last about 6.5 years, and researchers will regularly monitor participants, looking for signs that the cancer is spreading again or for any other health changes. The results will help determine how long participants stay free from metastasis, which means the cancer spreading to new areas, by using imaging tests and assessments.

Official TitleAn International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)

NCT05939414

Principal SponsorNovartis Pharmaceuticals

Study ContactNovartis PharmaceuticalsMore contacts

Last updated: March 24, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed/pelvic nodes)) or External beam Radiation Therapy (EBRT), (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. Biochemical recurrence (BCR) is defined as: nadir PSA + 2 ng/mL post XRT (if participant received-radiation therapy to intact prostate) and PSA > 0.2 ng/mL and rising post RP (with or without post-operation Radiation Therapy (RT))

Participants must have a negative CI for M1 disease at screening. Note: For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or post-traumatic changes or Paget's disease in bone lesions). For CI assessments, bone lesions must be assessed by bone scan only and soft tissue lesions must be assessed by CT/MRI scans only at screening.

Non-castration testosterone level >100 ng/dL at screening

Histologically confirmed prostate cancer prior to randomization

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14 exclusion criteria prevent from participating

Prior therapy with: ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment

Other hormonal therapy. e.g., Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment. Same medications are allowed if used for other indications: e.g., Benign Prostatic Hyperplasia (BPH), if stopped ≥3 months before randomization.

Immunotherapy (e.g., sipuleucel-T)

Any other investigational or systemic agents for metastatic disease

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 140 locations

Recruiting

Highlands Oncology Group

Fayetteville, United StatesOpen Highlands Oncology Group in Google Maps

Recruiting

VA Greater LA Healthcare System

Los Angeles, United States

Recruiting

VA Palo Alto Health Care System

Palo Alto, United States

Recruiting

Stanford University

Palo Alto, United States

Recruiting

140 Study Centers