Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan with Observation in Patients with PSMA Positive Oligometastatic Prostate Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05939414

Provider View

This study is testing a new treatment, lutetium (177Lu) vipivotide tetraxetan, to see if it can safely and effectively control prostate cancer that has spread to a few areas after initial treatment. The goal is to prevent the cancer from becoming more serious while maintaining quality of life by delaying hormone therapy.

Patient Parameters

Program Overview

The study aims to find out if lutetium (177Lu) vipivotide tetraxetan can help manage prostate cancer that has spread to a few areas (oligometastatic prostate cancer) after initial treatment. Researchers hope this treatment can stop the cancer from progressing to a more severe stage and delay the need for hormone therapy, which can affect quality of life.

Description

Participants in this study will first be checked to see if they qualify. They will have scans and tests to assess their cancer, including a special PET/CT scan to look for prostate cancer spread. In some countries, a different type of PET/CT scan may be used.

All participants will receive a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) to target cancer spots before starting the study treatment or observation.

  • The radiation therapy will take about 3 weeks.
  • Participants will be randomly assigned to either receive the study drug (AAA617) for up to 4 cycles or be observed without additional treatment after radiation.
  • Participants will have visits every week during the first and third weeks of each cycle and every 16 weeks after that until the cancer progresses.
  • The study will last about 6.5 years.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer before joining the study.
  • Must have prostate cancer that has returned after initial treatment, such as surgery or radiation.
  • Must have cancer that has spread to 5 or fewer areas, as shown by a special PET/CT scan.
  • At least one cancer spot must be a distant metastasis.
  • Must have no signs of cancer spread on regular imaging tests.
  • All cancer spots must be treatable with radiation therapy.
  • Must have normal testosterone levels.

Exclusion Criteria

  • Cancer that has spread to multiple areas at the start of the study.
  • Severe bladder or urinary issues that cannot be managed.
  • Previous treatments with hormone therapy, certain cancer drugs, or radiation therapy within specific timeframes.
  • Current use of certain cancer treatments or investigational drugs.
  • Other serious health conditions or cancers that could affect life expectancy or interfere with the study.
  • Heart problems that pose a risk to safety.
  • Immediate need for hormone therapy as determined by the doctor.

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