PSMA-directed EndoRadiotherapy of Castration-resISTant prostate cancer (PERCIST). IND # 133661
This is a targeted radionuclide therapy for metastatic Castration resistant (Hormone refractory) prostate cancer. This treatment is offered for the first time in U.S.
I would highly appreciate if you can inform the patients regarding the availability of this treatment at our center. The treatment appears to be very promising. Attached, please find a recently published peer reviewed manuscript regarding this treatment. Following is one example of patients benefited from this therapy:
Please contact Ms. Susan Cork , Senior Therapy Coordinator, Excel Diagnostics and Nuclear Oncology Center at 713-341-3203 or firstname.lastname@example.org for referral or further information.
- Prostate cancer proven by histopathology
- Unresectable metastases
- Progressive disease, both docetaxel naive and docetaxel treated.
- Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT)
- Positive 68Ga-PSMA-11 PET/CT or diagnostic 177Lu-PSMA-617 scintigraphy
- ECOG 0-2
- Sufficient bone marrow capacity as defined by WBC ≥2500/μl, PLT count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and WBC ≥2.000/μl, PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent cycles
- Signing of the Informed Consent Form
- Patients enrolling in this trial should have received either enzalutamide or abiraterone
- Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.
- Glomerular Filtration Rate (GFR) <40 ml/min
- serum creatinine>1.5xULN
- AST and ALT >5xULN
- Urinary tract obstruction or marked hydronephrosis
- Patients who had received both docetaxel and cabazitaxel will be excluded from this study. Enrolment will be limited to patients who had received prior docetaxel only.
- Diffuse bone marrow involvement confirmed by super-scans
Test Product; Dose; and Mode of Administration: Randomization into two treatment doses; radioligand therapy (RLT) by repeated i.v. application of 6.0 GBq (±10%, arm 1) or 7.4 GBq (±10%, arm 2) 177Lu-PSMA-617 every 8±1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry after the first treatment.
Study Duration: Patients will be followed until either of the following conditions occur: 1. 24 month after the first treatment. 2. Progression by RECIST 1.1/PCWG3 criteria. 3. Death.
For more information on Lu177-PSMA previous studies please clink HERE.