Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion session - Genitourinary tumours, prostate

1532 - Phase I dose-escalation study of fractionated dose 177Lu-PSMA-617 for progressive metastatic castration resistant prostate cancer (mCRPC)


21 Oct 2018


Poster Discussion session - Genitourinary tumours, prostate


Clinical Research

Tumour Site

Prostate Cancer


Scott Tagawa


Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284


S.T. Tagawa1, S. Vallabhajosula2, Y. Jhanwar2, A. Hackett1, C. Oromendia3, M.J. Naiz4, S.J. Goldsmith2, D.M. Nanus5, H. Beltran5, A.M. Molina1, B. Faltas1, J. Sreekumar1, J. Babich2, K. Ballman3, N.H. Bander4

Author affiliations

  • 1 Hematology And Medical Oncology, Weill Cornell Medical College, 10065 - New York/US
  • 2 Radiology, Weill Cornell Medical College, 10065 - New York/US
  • 3 Department Of Healthcare Policy & Research, Weill Cornell Medical College, 10065 - New York/US
  • 4 Urology, Weill Cornell Medical College, 10065 - New York/US
  • 5 Division Of Hematology And Medical Oncology, Weill Cornell Medical College, 10065 - New York/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 1532


PSMA is selectively overexpressed in advanced PC with upregulation by androgen receptor (AR) pathway dysregulation; limited expression in other organs. PC is radiosensitive with dose-response data. Dose-fractionation may allow delivery of higher total doses with less radioresistance than doses several weeks to months apart. Small molecule PSMA inhibitor ligands can be successfully radiolabeled and have been used for imaging and treatment, but no dose-escalation study has been performed.


Progressive mCRPC following at least 1 potent AR-targeted agent (e.g. abi/enza) and docetaxel (or unfit/refuse chemo) without limit of # prior therapies provided adequate organ function, ECOG performance status 0-2, and without preselection for PSMA expression were enrolled. Treatment was a single cycle of fractionated dose 177Lu-PSMA-617 on D1 and D15 starting at 7.4 GBq with planned escalation up to 22.2 GBq in modified 3 + 3 dose-escalation. Primary endpoint is determination of dose limiting toxicity (DLT) and recommended phase 2 dose (RP2D) with secondary efficacy endpoints. Pre- and post-treatment 68Ga-PSMA11 PET/CT and post-treatment 177Lu-PSMA-617 imaging was performed in addition to standard serial CT and bone scans.


29 men with median age 70 (range 56-87), median PSA 98.9 (range 6-2222) were treated. 93% with bone, 25% node, 14% lung, 7% liver, 7% other visceral metastases. 52% with at least 1 chemo, 45% >1 prior potent AR therapy, 17% with Ra223, 10 sip-T, 3% 177Lu-J591. No DLT was seen at any planned dose-level. With follow up ongoing, 41% with >50% PSA decline. Of 14 with paired CTC counts (CellSearch), 64% decreased, 14% stable, 14% increased (with 28.6% undetectable at 12 weeks). Adverse events include 55% xerostomia, 27.6% fatigue, 27.6% nausea, 27.6% thrombocytopenia, 20.7% anemia, 17.2% back pain. All had some PSMA uptake on imaging, with median (range) SUVmax 25 (4-119) bone, 32 (7-111) node, 10 (3-16) visceral.


Dose-escalation of 177Lu-PSMA-617 is safe up to 22.2 GBq per cycle with fractionated dosing, with promising early efficacy and tolerability signals. Enrollment to the phase 2 study at RP2D will provide additional efficacy and toxicity data.

Clinical trial identification


Legal entity responsible for the study

Weill Cornell Medical College.


Weill Cornell Medical College, Prostate Cancer Foundation, National Institutes of Health.

Editorial Acknowledgement


All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.