Metastatic Renal CancerPhase 3NCT06959433
Lu-177 PSMA Treatment in Cell Renal Carcinoma
A Phase 3 study testing Lu-177 PSMA-617 in people with Metastatic Renal Cancer, run by Ankara University.
Trial summary
Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cancer
- What is being tested?
- Lu-177 PSMA-617
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Aug 2028
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies
- At least 3 years of life expectancy
- ECOG performance status ≤ 2
- Ability to sign informed consent
Who cannot join
- Age<18
- Not having received any systemic therapies
- History of a secondary malignancy
- ECOG performance status > 2
- Any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression
- Previous history of any radionuclide therapies
- Inability to sign informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma
Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest.
PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.
- Conditions
- Metastatic Renal Cancer
- Being tested
- Lu-177 PSMA-617
- Keywords
- Renal Cell Carcinoma, Radionuclide treatment, efficacy, safety.
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu-177 PSMA-617Drug
Included patients will receive 4 cycles of 7.4GBq Lu-177 PSMa therapy every 6 weeks. If any toxicity develops after the first cycle, dose reduction will be performed for the other cycles. At 1. And 4. Cycles of therapy, whole body planar and SPECT/CT imaging will be performed at 4. And 24. Hours and any time at 4-7.days of injection. On these images , kindey, liver and salivary gland doses will be calculated. Mean tumor dose will also be calculated by measurinf the tumoral uptake. In the follow up, patients will be controlled at 9. And 24. Weeks and every 12 months then after.
| Study group | Role | What they receive |
|---|---|---|
| Lu-PSMA treatment arm | Experimental | Patients who will received Lu-177 PSMA treatment for metastatic RCC Receives: Drug: Lu-177 PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity analysis
Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.
Measured: 1-36 months
Secondary outcomes (1)
efficacy analysis
Therapy response will be evaluated according to RECIST 1.1 criteria
Measured: 1-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 May 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal CancerStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single arm will be included patients with metastatic RCC treated with Lu-177 PSMA
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Soydal, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959433
- Sponsor's protocol ID
- Lu-PSMA RCC
- Status last verified
- Feb 2026
- First submitted
- 28 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma
- ClinicalTrials.gov ID
- NCT06959433
- Acronym / sponsor ID
- Lu-PSMA RCC
- Conditions
- Metastatic Renal Cancer
- Keywords
- Renal Cell Carcinoma, Radionuclide treatment, efficacy, safety.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 May 2025 (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.
Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest.
PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single arm will be included patients with metastatic RCC treated with Lu-177 PSMA
| Arm | Type | Receives |
|---|---|---|
| Lu-PSMA treatment arm | Experimental | Drug: Lu-177 PSMA-617Patients who will received Lu-177 PSMA treatment for metastatic RCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18
- Progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies
- At least 3 years of life expectancy
- ECOG performance status ≤ 2
- Ability to sign informed consent
Key exclusion criteria (7 listed)
- Age<18
- Not having received any systemic therapies
- History of a secondary malignancy
- ECOG performance status > 2
- Any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression
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 |
|---|---|---|
| Lu-177 PSMA-617Included patients will receive 4 cycles of 7.4GBq Lu-177 PSMa therapy every 6 weeks. If any toxicity develops after the first cycle, dose reduction will be performed for the other cycles. At 1. And 4. Cycles of therapy, whole body planar and SPECT/CT imaging will be performed at 4. And 24. Hours and any time at 4-7.days of injection. On these images , kindey, liver and salivary gland doses will be calculated. Mean tumor dose will also be calculated by measurinf the tumoral uptake. In the follow up, patients will be controlled at 9. And 24. Weeks and every 12 months then after. | Drug | Lu-PSMA treatment arm |
Primary outcome
toxicity analysis
Time frame: 1-36 months
Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.
1 secondary outcome
efficacy analysis
Time frame: 1-36 months
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Renal Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lu-177 PSMA-617 in people with Metastatic Renal Cancer, run by Ankara University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Cigdem Soydal, Prof (+905333137701, csoydal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
toxicity analysis (time frame: 1-36 months). 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 27 Feb 2026.