Oligometastatic Prostate AdenocarcinomaPhase 2ANDROMEDANCT07150715
Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma
A Phase 2 study testing Actinium Ac 225 Vipivotide Tetraxetan, Biospecimen Collection and Gallium Ga 68 Gozetotide in people with Oligometastatic Prostate Adenocarcinoma and Recurrent Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Adenocarcinoma, Recurrent Prostate Adenocarcinoma
- What is being tested?
- Actinium Ac 225 Vipivotide Tetraxetan, Biospecimen Collection and Gallium Ga 68 Gozetotide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 31 Oct 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Christy Palodichuk, 310-825-9775, cpalodichuk@mednet.ucla.edu
Care Felix, 3108259771, cfelix@mednet.ucla.edu
About this study
Official title: Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide Combined With Metastasis-Directed Stereotactic Body Radiotherapy for Oligorecurrent Prostate Adenocarcinoma (ANDROMEDA)
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. They bind to a protein called a PSMA receptor, which is found on some prostate tumor cells. 225Ac-PSMA-617 or 177Lu-PSMA-617 builds up in these cells and gives off either alpha or beta radiation that may kill them. It is a type of radioconjugate and a type of PSMA analog. Stereotactic body radiation therapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving 225Ac-PSMA-617 or 177Lu-PSMA-617 and metastasis directed stereotactic body radiotherapy may be effective in treating patients with recurrent, oligometastatic prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess progression-free survival for men with oligorecurrent prostate cancer after stereotactic body radiotherapy (SBRT) in combination with 2 cycles of Lutetium Lu 177 Vipivotide Tetraxetan (177Lu-PSMA-617) versus SBRT in combination with 1 cycle of Actinium Ac 225 Vipivotide Tetraxetan (225Ac-PSMA-617), with progression defined on the basis of prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans obtained at 24 months post-SBRT or at the time of prostate specific antigen (PSA)-based biochemical progression, initiation of salvage therapy or death.
SECONDARY OBJECTIVES:
- To evaluate burden of disease (including local control of irradiated lesions and presence of other disease) on a PSMA PET/CT obtained 24 months after SBRT + 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease who have not progressed by that point.
II. To assess physician-scored toxicity (common terminology criteria for adverse events [CTCAE] version 5.0) of SBRT + 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease.
III. To assess patient-reported quality of life (based on the Xerostomia Inventory scale) after SBRT + 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease.
IV. To assess androgen deprivation therapy (ADT)-free survival after 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617 in patients with oligometastatic disease.
- To determine local control of irradiated lesions at 24 months after last radionuclide infusion in patients with oligometastatic disease (based on a scheduled PSMA-PET), comparing 177Lu-PSMA-617 versus SBRT + 225Ac-PSMA-617.
VI. To assess time to locoregional progression, time to distant progression, time to new metastasis, and duration of response after last radionuclide infusion in patients with oligometastatic disease (as defined by PSMA PET/CT).
CORRELATIVE OBJECTIVES:
- To quantitatively sequence T-cell receptor (TCR) repertoires using peripheral blood monocytes at baseline, 3 months, 6 months, and 12 months after last infusion of radionuclide.
II. To perform radiomics analysis on PSMA PET/CT scans performed at 24 months after last infusion of radionuclide, or at time of progression.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 177Lu-PSMA-617 intravenously (IV) over 1-10 minutes on day one of each cycle. Cycles repeat every 6 weeks for 2 cycles. 4-6 weeks after completion of 177Lu-PSMA-617 patients receive Gallium Ga 68 Gozetotide (68Ga-PSMA-11) IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT for 1-5 treatments over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.
ARM II: Patients receive 225Ac-PSMA-617 IV once. 4-6 weeks after completion of 225Ac-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years and at 60 months.
- Being tested
- Actinium Ac 225 Vipivotide Tetraxetan, Biospecimen Collection, Gallium Ga 68 Gozetotide, Lutetium Lu 177 Vipivotide Tetraxetan, PSMA PET-CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actinium Ac 225 Vipivotide TetraxetanDrug
Also called 225Ac-labeled PSMA-617, 225Ac-PSMA-617, 225Ac-Vipivotide Tetraxetan, Actinium (225AC) PSMA-617
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Gallium Ga 68 GozetotideOther
Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Given IV
Lutetium Lu 177 Vipivotide TetraxetanDrug
Also called 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617
Given IV
PSMA PET-CT ScanProcedure or surgery
Also called PET-CT (PSMA), Prostate-specific Membrane Antigen PET-CT, PSMA PET-CT
Undergo PSMA PET/CT scan
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (177Lu-PSMA-617) | Experimental | Patients receive 177Lu-PSMA-617 IV, over 1-10 minutes, on day one of each cycle. Cycles repeat every 6 weeks for 2 cycles. 4-6 weeks after completion of 177Lu-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study. Receives: Drug: Actinium Ac 225 Vipivotide Tetraxetan; Procedure: Biospecimen Collection; Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: PSMA PET-CT Scan; Radiation: Stereotactic Body Radiation Therapy |
| Arm II (225Ac-PSMA-617) | Experimental | Patients receive 225Ac-PSMA-617 IV once. 4-6 weeks after completion of 225Ac-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study. Receives: Drug: Actinium Ac 225 Vipivotide Tetraxetan; Procedure: Biospecimen Collection; Other: Gallium Ga 68 Gozetotide; Procedure: PSMA PET-CT Scan; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
A progression event will be based on prostate specific membrane antigen positron emission tomography/ computed tomography findings triggered either by a prostate specific antigen rise or at the timepoint defined by 24 months measured from the final radionuclide infusion (i.e., second infusion of 177Lu-PSMA-617 and first infusion of 225Ac-PSMA-617). The Kaplan-Meier (KM) method will be used to summarize PFS and log-rank test will be used to compare PFS between the two arms.
Measured: From the date of randomization to the date of disease progression or death, whichever happens earlier, up to 5 years
Secondary outcomes (8)
Incidence of adverse events (AEs)
AEs will be summarized by type and grade.
Measured: From time of randomization, up to 5 years
Androgen deprivation therapy free survival
The KM method will be used to summarize.
Measured: Up to 5 years
Time to locoregional progression
The KM method will be used to summarize.
Measured: Up to 5 years
Time to new metastasis
The KM method will be used to summarize.
Measured: Up to 5 years
Overall survival
The KM method will be used to summarize.
Measured: Up to 5 years
Local control
Will be defined based on PSMA PET/CT criteria, with scans obtained at time of PSA-progression of 24 months (if no progression by either time point). Patients with complete response, partial response, or stable disease will be considered as exhibiting local control. The proportion of lesions that have a stable or better response will be estimated using generalized estimating equation. The KM method will be used to summarize.
Measured: Up to 5 years
Duration of response over time
The KM method will be used to summarize.
Measured: Up to 5 years
Quality of life as measured by xerostomia inventory
Will be evaluated based on responses to the xerostomia inventory.
Measured: At baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start12 Dec 2025
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Amar Kishan, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150715
- Sponsor's protocol ID
- 25-1338
- Other IDs
- NCI-2025-05583
- Acronym
- ANDROMEDA
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes