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A dosimetry study of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer
EU CTIS ID: 2024-515264-31-00
What this study is testing
To compare the therapeutic index of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male patient aged ≥60 years old at Visit 1 (Screening)
- 2. Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing, has undergone, or is being planned for systemic therapy.
- 3. At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry.
- 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 5. Adequate normal organ function.
- 6. Willing to provide signed and dated written informed consent form (ICF) prior to any study-specific procedures.
You likely can't join if
- 1. Known hypersensitivity to lutetium (177Lu) rhPSMA-10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents.
- 2. Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 physical half-lives (whichever is longer) prior to Visit 1 (Screening).
- 3. Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
- 4. Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol.
- 5. Any change to prostate cancer medication, initiation of other prostate cancer therapy (e.g. radiotherapy), or prostate cancer surgical procedure within 42 days prior to screening and/or during study participation.
- 6. For any patients receiving androgen deprivation therapy (ADT), any change in dose in the last 8 weeks prior to Visit 1 (Screening) will make them ineligible for the study.
See the full eligibility criteria
- 1. Male patient aged ≥60 years old at Visit 1 (Screening)
- 2. Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing, has undergone, or is being planned for systemic therapy.
- 3. At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry.
- 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 5. Adequate normal organ function.
- 6. Willing to provide signed and dated written informed consent form (ICF) prior to any study-specific procedures.
- 7. Male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment. In addition, they must agree to use effective contraception for this same period to protect partners from any exposure to the investigational products.
- 1. Known hypersensitivity to lutetium (177Lu) rhPSMA-10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents.
- 2. Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 physical half-lives (whichever is longer) prior to Visit 1 (Screening).
- 3. Any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations.
- 4. Severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the SPECT/CT scan protocol.
- 5. Any change to prostate cancer medication, initiation of other prostate cancer therapy (e.g. radiotherapy), or prostate cancer surgical procedure within 42 days prior to screening and/or during study participation.
- 6. For any patients receiving androgen deprivation therapy (ADT), any change in dose in the last 8 weeks prior to Visit 1 (Screening) will make them ineligible for the study.
- 7. Any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator’s judgement, makes the patient ineligible for the study.
- 8. Participation in other studies involving other IMPs within 42 days or 5 half-lives (whichever is longer) prior to Visit 1 (Screening) and/or during study participation.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.