Prostate CancerPhase 2PSMA-ADJUVONCT06449781
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
A Phase 2 study testing Lutetium (177Lu) vipivotide tetraxetan in people with Prostate Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Lutetium (177Lu) vipivotide tetraxetan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 9 Jan 2025to Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Giving a written informed consent
- Histopathologically confirmed high or very high risk prostate cancer
- Completion of radical locoregional treatment
- Completion of locoregional treatment within 3 months before inclusion to the study
- ECOG performance status 0 to 2
- Age over 18 years
Show all 20Show fewer
- Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
- Castrate testosterone level (testosteron < 50 ng/dL lub 1,7 nmol/L)
- Patients with adequate function of main organs:
- bone marrow:
- neutrophils > 1500x10^9/L;
- thrombocytes > 100,000x10^9/L;
- hemoglobin > 9 g/dL
- liver:
- bilirubin < 2xULN (upper limit of normal) in patients with Gilbert's syndrome < 5xULN;
- aminotransferase < 3xULN
- kidneys:
- eGFR > 50 ml/min
- albumin >2.5 mg/ml
- For men of reproductive age: the need to use double barrier contraception
Who cannot join
- The presence of distant metastases confirmed by radiological examination
- Absence of approval to use effective contraception method
- Absence of Patient's consent to participate in the Study
- Urinary tract obstruction or/and hydronephrosis.
- Concurrent anticancer treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-101
Tomasz Lachcik, +48322789791, tomasz.lachcik@gliwice.nio.gov.pl
Daria Handkiewicz-Junak, Prof.
About this study
Official title: 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy
Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy
Read the detailed description
The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.
The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy
Participation time in the Study:
intervention phase - 1 day; observation phase - 5 years
- Conditions
- Prostate Cancer
- Being tested
- Lutetium (177Lu) vipivotide tetraxetan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium (177Lu) vipivotide tetraxetanDrug
Also called Pluvicto
The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The intervention will consist of a single administration of 177Lu-PSMA with an activity of 7.4 GBq. Participants will also receive standard hormone therapy Receives: Drug: Lutetium (177Lu) vipivotide tetraxetan |
| Control | No intervention | Participants will receive standard hormone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effectiveness
Assessment of treatment failure - the assesment of biochemical progression ratio, defined as a rise of PSA by 2 ng/mL or more above the nadir, proven by a consecutive examination performed at least 4 weeks later
Measured: 2 and 5 years after end of treatment
Secondary outcomes (5)
Biochemical progression-free survival
Comparative assessment of biochemical progression-free survival time defined as an increase in tPSA (prostate specific antigen) in the blood above the nadir (the lowest PSA value after completion of treatment) by 2 ng/mL or more, confirmed in the next test performed no earlier than after 4 weeks
Measured: During the intervention and follow up period (assessed up to 5 years)
Radiological progression-free survival
Comparative assessment of radiological progression-free survival defined according to PCWG3 criteria
Measured: During the intervention and follow up period (assessed up to 5 years)
Time until the next therapeutic intervention
Comparative assessment of the time until the next therapeutic intervention
Measured: During the intervention and follow up period (assessed up to 5 years)
Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0
Comparative assessment of safety and tolerability of treatment according to CTCAE v 5.0
Measured: During the intervention and follow up period (assessed up to 5 years)
Quliaty of life
Comparison of EORTC QLQ-PR25 quality of life indicators between study groups
Measured: During the intervention and follow up period (assessed up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start9 Jan 2025
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Model description
- Open-label, two-arm, randomized study.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449781
- Sponsor's protocol ID
- PSMA-ADJUVO
- Other IDs
- Nr EU CT: 2023-504912-13-00
- Acronym
- PSMA-ADJUVO
- Status last verified
- Oct 2026
- First submitted
- 6 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy
- ClinicalTrials.gov ID
- NCT06449781
- Acronym / sponsor ID
- PSMA-ADJUVO / PSMA-ADJUVO
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy
Detailed description
The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.
The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy
Participation time in the Study:
intervention phase - 1 day; observation phase - 5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, two-arm, randomized study.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Lutetium (177Lu) vipivotide tetraxetanThe intervention will consist of a single administration of 177Lu-PSMA with an activity of 7.4 GBq. Participants will also receive standard hormone therapy |
| Control | No intervention | –Participants will receive standard hormone therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Giving a written informed consent
- Histopathologically confirmed high or very high risk prostate cancer
- Completion of radical locoregional treatment
- Completion of locoregional treatment within 3 months before inclusion to the study
- ECOG performance status 0 to 2
Key exclusion criteria (5 listed)
- The presence of distant metastases confirmed by radiological examination
- Absence of approval to use effective contraception method
- Absence of Patient's consent to participate in the Study
- Urinary tract obstruction or/and hydronephrosis.
- Concurrent anticancer treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutetium (177Lu) vipivotide tetraxetanAlso: PluvictoThe intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan | Drug | Experimental |
Primary outcome
Treatment effectiveness
Time frame: 2 and 5 years after end of treatment
Assessment of treatment failure - the assesment of biochemical progression ratio, defined as a rise of PSA by 2 ng/mL or more above the nadir, proven by a consecutive examination performed at least 4 weeks later
5 secondary outcomes
Biochemical progression-free survival
Time frame: During the intervention and follow up period (assessed up to 5 years)
Radiological progression-free survival
Time frame: During the intervention and follow up period (assessed up to 5 years)
Time until the next therapeutic intervention
Time frame: During the intervention and follow up period (assessed up to 5 years)
Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0
Time frame: During the intervention and follow up period (assessed up to 5 years)
Quliaty of life
Time frame: During the intervention and follow up period (assessed up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lutetium (177Lu) vipivotide tetraxetan in people with Prostate Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daria Handkiewicz-Junak (48322789339, daria.handkiewicz-junak@gliwice.nio.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effectiveness (time frame: 2 and 5 years after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.