* CAAA617C12301 - Metastatic hormone sensitive prostate cancer
Research type
Research Study
Full title
PSMAddition: An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
IRAS ID
296903
Contact name
Robert Jones
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-003968-56
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 3 months, 11 days
Research summary
Prostate cancer is a disease which occurs in males in a small gland in the body called the prostate. In some cases, the disease may spread beyond the gland and affect different parts of the body developing metastases; in these cases, treatment will be required. This is a phase III open label study with the aim of determining if a new experimental drug named 177Lu-PSMA-617 given with androgen deprivation therapy (also called ADT) and androgen receptor targeted therapy (also called ARDT) is safe and effective as a treatment for men with metastatic hormone-sensitive prostate cancer (mHSPC). 177Lu-PSMA-617 is a radioligand therapy which targets prostate cancer cells because it binds specifically to the prostate cancer cells. When the therapy binds to the prostate cancer cells, Lutetium-177 (a radioactive metal) is delivered to the tumour with the aim of destroying the cancer cells. 177Lu-PSMA-617 has been studied in prostate cancer in over 50 studies and in over 1000 participants. This study is for participants that have either never received ADT and/or have received minimal treatment (up to 45 days) of ADT or had a surgery with or without first generation anti-androgen drugs (e.g. bicalutamide, flutamide) for metastatic prostate cancer. Eligible participants may have also received up to 45 days of ARDT as well as prior surgery or radiation to the prostate.
Approximately 1126 men in approximately 20 countries will take part in the study. Participants will be part of the study for approximately 56 months and will have a 50% probability of initially receiving 177Lu-PSMA-617 (radionuclide therapy) along with ADT and ARDT at the same time. Men assigned to the control group will receive ADT and ARDT alone, and then if eligible will be allowed to receive 177Lu-PSMA-617 once their disease progresses (worsens).
REC name
London - Westminster Research Ethics Committee
REC reference
21/FT/0073
Date of REC Opinion
29 Jun 2021
REC opinion
Further Information Favourable Opinion