Tuesday, August 11, 2020

PSMA-targeted radiopharmaceutical clinical trials in the US

(frequently updated)

Now that the VISION trial of Lu-177-PSMA-617 is no longer recruiting, some patients are wondering if they can still get PSMA-targeted radiopharmaceuticals in the US, without traveling to Germany, Australia, India, etc. Here is a list of trials that are active, still open to recruitment, or will soon be recruiting. 

Unless otherwise noted, they are all for men who are: 

  • metastatic
  • castration-resistant 
  • have had at least one taxane chemotherapy
  • at least one of the advanced androgen receptor therapies (e.g., Zytiga, Xtandi, Erleada, or Nubeqa)
  • no Xofigo
  • PSMA-avid on a PSMA PET/CT scan

Radiopharmaceutical

Adjuvant drugs

Extra criteria

Recruitment status/ contact

Locations

Ac-225-PSMA-R2


•After or without prior Lu-177-PSMA

Begins 10/23

TBD

Lu-177-PSMA-617

PSMACare

1. ADT

2.ARSi+ADT (ARSi=Zytiga, Xtandi,Erleada or Nubeqa)

•Metastatic with PSMA PET, but not with conventional imaging

•CRPC

•No prior ARSi or chemo

Begins 12/23

TBD

Lu-177-PNT2002

LUNAR

Before SBRT

Recurrent and oligometastatic

recruiting

UCLA


Lu-177-rhPSMA-10.1


±previous chemo

recruiting 

•Maryland

•St.Louis

•Omaha

•Mt Sinai-NYC

Lu-177-PSMA-I&T


Chemo naïve, failed one hormonal

recruiting

• 58 locations

Ac-225-PSMA-I&T

TATCIST



Recruiting

• Houston

Ac-225-J591

 

 

recruiting

• Weill Cornell

• Brooklyn Methodist

Pluvicto+ONC392 (a CTL4 blocking immunotherapy)



Begins 9/23

• NYU Langone

• Columbia

• Maryland

• Omaha

• Duke

• UTSW (Dallas)

•UWisc. Carbone

Ac-225-J591 + Lu-177-PSMA- I&T

 


Suspended

• Weill Cornell

• Brooklyn Methodist

Ac-225-J591

Keytruda

No chemo since castration resistant

recruiting

• Weill Cornell

• Brooklyn Methodist

• Dana Farber

• Columbia

Cu-67-SAR-bisPSMA

SECuRE

 

Previous chemo OK, not required

recruiting

• Johns Hopkins

•Mayo Rochester

•Mayo, AZ

•Tulane, N.O.

•Barnes Jewish, St. Louis

•Omaha, NE

•Weill Cornell

Lu-177-PSMA-617

PSMAddition


mHSPC

(M1 or N1)

Treatment naive

Recruiting

• 188 sites

Lu-177-PSMA-617

Keytruda

No chemo since castration resistant

active, not recruiting

UCSF

Lu-177-CTT1403

 

No Jevtana

active, not recruiting

UCSF

Lu-177-PSMA-617

 

 

Active, not recruiting

•Weill Cornell

•Tulane

Th-227-Antibody

(see article)

 

 

active, not recruiting

• Royal Marsden (UK)

• Finland

• Tulane

• MSK

• Omaha, NE

Lu-177-J591

Ketoconazole

Prior RP or RT

CRPC

Non-metastatic

active, not recruiting

• Weill Cornell

• USC

• Georgetown

• IU

• U of Iowa

• UPMC

Lu-177-PSMA-R2

 

 

Active, not recruiting

• Stanford

• Yale

• Tulane

• Johns Hopkins

• Mt Sinai

• MD Anderson

• U of Wisconsin

• Phoenix

Lu-177-PSMA-617

PSMAfore

 

Chemo and immunotherapy naïve, failed one hormonal

Active, not recruiting

(Phase 3 RCT)

• 72  sites

Lu-177-PSMA-617

(VISION)

 

 

Active, not recruiting

• 84 locations

Results expected August 2020

I-131-1095-MIPS

(see article)

Xtandi

Chemo naïve

Failed Zytiga

Active, not recruiting

• 17 locations

Results expected December 2021