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New treatment option for Oligometastatic Prostate Adenocarcinoma
Official title Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
ClinicalTrials.gov ID: NCT07150715
What this study is testing
What is Actinium Ac 225 Vipivotide Tetraxetan?
Actinium Ac 225 Vipivotide Tetraxetan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oligometastatic prostate adenocarcinoma.
Also referred to as 225Ac-labeled PSMA-617, 225Ac-PSMA-617.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial compares the use of 225Ac-PSMA-617 to 177Lu-PSMA-617, along with stereotactic body radiotherapy for the treatment of prostate cancer that has come back after a period of improvement (recurrent) and that has spread from where it first started (primary site) to multiple other places in the body (oligometastatic). 225Ac-PSMA-617 and 177Lu-PSMA-617 are radioactive drugs.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA...
- Serum testosterone \> 150 ng/dL
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- No indication for urgent or emergent radiation
You likely can't join if
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Patients with castrate-resistant disease (i.e., prostate specific antigen [PSA] \> 0.5 ng/mL with serum testosterone \<150 ng/dL)
- Patients who received androgen deprivation therapy or cytotoxic chemotherapy within 6 months of trial enrolment
- Concurrent systemic therapy for a solid organ malignancy
- Spinal cord compression
- Inability to lie flat
See the full eligibility criteria
- Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers
- Serum testosterone \> 150 ng/dL
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- No indication for urgent or emergent radiation
- Histological confirmation of prostate adenocarcinoma (histology from original treatment acceptable)
- White blood cell count ≥ 2.5 × 109/L
- Platelets ≥ 100 × 109/L
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 × institutional upper limits of normal (ULN) or up to 3 × ULN if known history of Gilbert's syndrome
- Alanine aminotransferase or aspartate aminotransferase ≤ 3.0 × ULN or ≤ 5.0 × ULN for patients with liver metastases
- Glomerular filtration rate creatinine-cystatin C (GFRcr-cys) ≥ 60 mL/min 1.73m2 using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 equation
- Serum albumin \> 3.0 g/dL
- Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration
- Ability to understand, and willingness to sign, the written informed consent
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Patients with castrate-resistant disease (i.e., prostate specific antigen [PSA] \> 0.5 ng/mL with serum testosterone \<150 ng/dL)
- Patients who received androgen deprivation therapy or cytotoxic chemotherapy within 6 months of trial enrolment
- Concurrent systemic therapy for a solid organ malignancy
- Spinal cord compression
- Inability to lie flat
- Known hypersensitivity to components of 177-Lu-PSMA-617 or 225-Ac-Lu-PSMA-617
- Inadequate renal function of GFRcr-cys \< 60 mL/min 1.73m2 using the CKD-EPI 2021equation
- Total bilirubin \> 1.5 × ULN or \> 3.0 × ULN if known history of Gilbert's syndrome
- Alanine aminotransferase or aspartate aminotransferase \> 3 × ULN (or 5 × ULN for patients with known liver metastases)
- De novo oligometastatic disease
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, 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 ClinicalTrials.gov; the study team decides eligibility.