Lu-177 PSMA Treatment in Cell Renal Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age<18

Not having received any systemic therapies

History of a secondary malignancy

ECOG performance status > 2

Trial design

Design model

Single group

Treatments tested in this trial

  • Lu-177 PSMA-617

    Drug

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Lu-PSMA treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

toxicity analysis

Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.

Time frame
1-36 months

Secondary outcomes

1

efficacy analysis

Therapy response will be evaluated according to RECIST 1.1 criteria

Time frame
1-36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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