We present the first patient treated with Lu-177-DKFZ- PSMA-617  for metastatic Castrate-resistant Prostate Cancer outside Europe.

63 years old patients, diagnosed with Prostate Cancer in 2004; Gleason 9, treated with radical prostatectomy and radiation therapy due to early biochemical relapse.  In 2012, bone metastases where diagnosed and hormonal therapy was initiated with multiple failure with different antiandrogens regimen  between 2012 and 2015.  In July 2015 an extensive bone involment was demonstrated with a bone scan. A PET/CT with Ga68-HBED-PSMA demonstrate visceral and bone metastases and  a rising  Prostatic Specif Antigen (PSA)  from 251 ng/mL up to 507 ng/mL in three months period. At that time the patient complained of bone pain, anemic, malaise (ECOG 3). The pain persisted in spite of opiates use.   Compassionate use of  Lu-177-DKFZ- PSMA-617  treatment was considered because of lack of response to other treatment alternative.

Before therapy a whole blood counts, creatinine, BUN, hepatic function test and PSA were performed.  After signed informed consent, 4,5 MBq of Lu-177-DKFZ- PSMA-617  was administrated by intravenous infusion over a period of 30 minutes.  No side effects were observed during 24 hours of hospitalization.  Whole body images and SPECT/CT of the abdomen performed at 24 hours showed very high uptake at bone and nodal metastases with very low background activity.  Lu-177-DKFZ- PSMA-617  nca from ITG and peptides; DKFZ- PSMA-617  and HBED-PSMA from ABX (Germany).

The biochemical follow up after therapy had shown a significant decreased in PSA level.  No hematological neither renal toxicity was observed.  One month after therapy the patient was able to stop opiates use and he related a significant decreased in bone pain with ECOG 0.