Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574880
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
STARLiT STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer A Phase III Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARLiT
Brief Summary:
The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer
Participants will receive one dose of Pluvicto followed by radiation about 6 weeks later Radiation therapy will be completed in 5 treatments over the period of 2 weeks A second dose of Pluvicto will be given 6 weeks after radiation is complete Some participants may also receive a third dose of Pluvicto and this would be given 6 weeks after the second dose of Pluvicto
Participants will receive one dose of Pluvicto followed by radiation about 6 weeks later Radiation therapy will be completed in 5 treatments over the period of 2 weeks A second dose of Pluvicto will be given 6 weeks after radiation is complete Some participants may also receive a third dose of Pluvicto and this would be given 6 weeks after the second dose of Pluvicto
Detailed Description:
Prostate cancer is the most common cancer in men worldwide and second leading cause of cancer death in men The most common treatment for prostate cancer is radiation therapy RT plus long-term androgen deprivation therapy ADT for 18-36 months with a consideration for the addition of abiraterone acetate
With the introduction of abiraterone and other second generation androgen signaling inhibitors ARSIs there is great interest in shortening the duration of systemic therapy This interest stems from the high toxicity rates of ADT and substantial impact on patient-reported quality of life QoL The use of ADT is associated with some adverse events Therefore the combination of adverse event risks and decrease in quality of life associated with castration have resulted in decreased compliance to long term ADT and even ARSIs where approximately 50 of patients with locally advanced disease either decline any ADT or stop treatment early The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer
This clinical trial will evaluate the safety of using Lu-PSMA-617 with SBRT to the prostate and pelvic lymph nodes and to determine whether Lu-PSMA-617 can replace androgen deprivation therapy ADT to improve oncologic outcomes by use of cytotoxic agents avoid ADT related side effects and improve compliance for participants to receive systemic therapy
With the introduction of abiraterone and other second generation androgen signaling inhibitors ARSIs there is great interest in shortening the duration of systemic therapy This interest stems from the high toxicity rates of ADT and substantial impact on patient-reported quality of life QoL The use of ADT is associated with some adverse events Therefore the combination of adverse event risks and decrease in quality of life associated with castration have resulted in decreased compliance to long term ADT and even ARSIs where approximately 50 of patients with locally advanced disease either decline any ADT or stop treatment early The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer
This clinical trial will evaluate the safety of using Lu-PSMA-617 with SBRT to the prostate and pelvic lymph nodes and to determine whether Lu-PSMA-617 can replace androgen deprivation therapy ADT to improve oncologic outcomes by use of cytotoxic agents avoid ADT related side effects and improve compliance for participants to receive systemic therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None