Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876651
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2021-05-03
Brief Title:
The Present Study Aims to Compare Patients Who Receive the Investigational Product 177Lu-DOTA-rosopatamab Plus Standard of Care in Comparison to Standard of Care Only
Sponsor:
Telix Pharmaceuticals Innovations Pty Ltd
Organization:
Telix Pharmaceuticals Innovations Pty Limited
Study Overview
Official Title:
A Multinational Multicenter Prospective Randomized Controlled Open Label Phase 3 Study With Best Standard of Care With and Without 177Lu-DOTA-rosopatamab for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSTACT
Brief Summary:
This multinational multicenter prospective randomized controlled open label Phase 3 study is designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody 177Lu DOTA rosopatamab administered together with Standard of Care SoC as compared to the best SoC alone The phase 3 will be conducted in patients with metastatic castration-resistant PC mCRPC that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug NAAD
Detailed Description:
This multinational multicenter prospective randomized controlled open label Phase 3 study is designed to investigate and confirm the benefits and risks associated with 177Lu DOTA rosopatamab administered together with SoC as compared to the best SoC alone in patients with PSMA-positive metastatic castration-resistant PC mCRPC that has progressed despite prior treatment with a novel androgen axis drug NAAD
PSMA positivity will be defined by gallium-68 labeled PSMA-11 68Ga-PSMA-11 positron emission tomographycomputerized tomography PETCT as at least one site of metastatic disease with intensity significantly greater than normal liver ie standardized uptake value SUV max at least 15 times SUV of normal liver
Approximately 392 eligible adult male will be part of this study 387 patients will be randomized to one of two groups in a 21 ratio to receive one of the treatments below 5 participants in New Zealand will be enrolled into a sub-study
Group A Two single intravenous IV injections of 76 mCi each equivalent to a 45 mCim2 dose in a standard 17m2 individual of 177Lu-DOTA- rosopatamab given 14 days apart plus best SoC
Group B Best SoC
In parallel to this 5 participants in New Zealand site will be enrolled into a sub-study to investigate the biodistribution pharmacokinetics and dosimetry of 177Lu-DOTA-TLX591m17 Participants will receive two doses of 177Lu-DOTA-TLX591m17 14 days apart
Screening procedures will take up to 28 days prior to enrollment and randomization Only patients with PSMA-positive metastatic PC and meeting all other inclusionexclusion criteria were randomized in a 21 ratio to Group A or B OR allocated to Sub-study in New Zealand
Participants in Group A or B will participate in the study for up to 5 years During this period the participants will undergo imaging procedures approximately every 6-8 weeks until progression
Participants in the sub-study will participate in the study up to 23 days During this period participants will receive two doses of 177Lu-DOTA-TLX591m17 14 days apart and undergo SPECTCT imaging and blood collection for Pharmacokinetics at days 1258 13 and 15
For all patients the best SoC will be determined by the Principal Investigator PI and the medication will be provided until progression
PSMA positivity will be defined by gallium-68 labeled PSMA-11 68Ga-PSMA-11 positron emission tomographycomputerized tomography PETCT as at least one site of metastatic disease with intensity significantly greater than normal liver ie standardized uptake value SUV max at least 15 times SUV of normal liver
Approximately 392 eligible adult male will be part of this study 387 patients will be randomized to one of two groups in a 21 ratio to receive one of the treatments below 5 participants in New Zealand will be enrolled into a sub-study
Group A Two single intravenous IV injections of 76 mCi each equivalent to a 45 mCim2 dose in a standard 17m2 individual of 177Lu-DOTA- rosopatamab given 14 days apart plus best SoC
Group B Best SoC
In parallel to this 5 participants in New Zealand site will be enrolled into a sub-study to investigate the biodistribution pharmacokinetics and dosimetry of 177Lu-DOTA-TLX591m17 Participants will receive two doses of 177Lu-DOTA-TLX591m17 14 days apart
Screening procedures will take up to 28 days prior to enrollment and randomization Only patients with PSMA-positive metastatic PC and meeting all other inclusionexclusion criteria were randomized in a 21 ratio to Group A or B OR allocated to Sub-study in New Zealand
Participants in Group A or B will participate in the study for up to 5 years During this period the participants will undergo imaging procedures approximately every 6-8 weeks until progression
Participants in the sub-study will participate in the study up to 23 days During this period participants will receive two doses of 177Lu-DOTA-TLX591m17 14 days apart and undergo SPECTCT imaging and blood collection for Pharmacokinetics at days 1258 13 and 15
For all patients the best SoC will be determined by the Principal Investigator PI and the medication will be provided until progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None