Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378866
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-16
Brief Title:
Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic Recurrent Hormone-Sensitive Prostate Cancer DIVINE Trial
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Dynamic Investigator Initiated Enterprise DIVINE in Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
DIVINE
Brief Summary:
This phase II trial studies the effects of stereotactic body radiation therapy SBRT and the timing of treatment with androgen receptor pathway inhibitor ARPI plus androgen deprivation therapy ADT in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body metastatic and that has come back after a period of improvement recurrent SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body except the brain The total dose of radiation is divided into smaller doses given over several days This type of radiation therapy helps spare normal tissue Androgen can cause the growth of prostate cells ADT lowers the amount of androgen made by the body This may help stop the growth of tumor cells that need androgen to grow Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate and compare modified radiographic progression-free survival mrPFS in patients with metachronous recurrent oligometastatic prostate cancer treated with SBRT and 6 months ADTARPI followed by watchful wait Group A versus SBRT followed by watchful wait Group B
SECONDARY OBJECTIVES
I To evaluate and compare overall survival OS between two treatment groups II To evaluate and compare biochemical progression-free survival bPFS between two treatment groups
III To evaluate and compare time to local progression between two treatment groups
IV To evaluate and compare time to distant progression between two treatment groups
V To evaluate the toxicity profile of 6 months of ADTARPI as assessed per National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE
TERTIARY OBJECTIVES
I To evaluate and compare castration-resistant prostate cancer CRPC-free survival between two treatment groups NOTE CRPC-free survival radiographic progression-free survival with castrate-level testosterone 50ngmL
II Determine the efficacy of extracellular vesicles EVs as a minimal residual disease MRD marker
III Determine the efficacy of EVs as an early indicator of disease relapse IV Characterize duration of response V Determine whether early ADT and ARPI hasten CRPC VI Determine how circulating tumor deoxyribonucleic acid ctDNA compares as a biomarker to EVs
OUTLINE Patients are randomized to 1 of 2 groups
GROUP A Patients undergo SBRT and receive ARPI abiraterone and prednisone apalutamide darolutamide or enzalutamide and ADT leuprolide triptorelin histrelin goserelin degarelix or relugolix Cycles repeat every 4 months 16 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity Patients then undergo watchful waiting thereafter until disease progression
GROUP B Patients undergo SBRT with watchful waiting Cycles repeat every 4 months 16 weeks in the absence of disease progression or unacceptable toxicity
Additionally patients undergo blood sample collection and positron emission tomography PET computed tomography CT magnetic resonance imaging MRI or bone scan
Upon completion of study interventions patients are followed up every 6 months for up to 5 years
I To evaluate and compare modified radiographic progression-free survival mrPFS in patients with metachronous recurrent oligometastatic prostate cancer treated with SBRT and 6 months ADTARPI followed by watchful wait Group A versus SBRT followed by watchful wait Group B
SECONDARY OBJECTIVES
I To evaluate and compare overall survival OS between two treatment groups II To evaluate and compare biochemical progression-free survival bPFS between two treatment groups
III To evaluate and compare time to local progression between two treatment groups
IV To evaluate and compare time to distant progression between two treatment groups
V To evaluate the toxicity profile of 6 months of ADTARPI as assessed per National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE
TERTIARY OBJECTIVES
I To evaluate and compare castration-resistant prostate cancer CRPC-free survival between two treatment groups NOTE CRPC-free survival radiographic progression-free survival with castrate-level testosterone 50ngmL
II Determine the efficacy of extracellular vesicles EVs as a minimal residual disease MRD marker
III Determine the efficacy of EVs as an early indicator of disease relapse IV Characterize duration of response V Determine whether early ADT and ARPI hasten CRPC VI Determine how circulating tumor deoxyribonucleic acid ctDNA compares as a biomarker to EVs
OUTLINE Patients are randomized to 1 of 2 groups
GROUP A Patients undergo SBRT and receive ARPI abiraterone and prednisone apalutamide darolutamide or enzalutamide and ADT leuprolide triptorelin histrelin goserelin degarelix or relugolix Cycles repeat every 4 months 16 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity Patients then undergo watchful waiting thereafter until disease progression
GROUP B Patients undergo SBRT with watchful waiting Cycles repeat every 4 months 16 weeks in the absence of disease progression or unacceptable toxicity
Additionally patients undergo blood sample collection and positron emission tomography PET computed tomography CT magnetic resonance imaging MRI or bone scan
Upon completion of study interventions patients are followed up every 6 months for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC230502 | OTHER | Mayo Clinic in Rochester | None |
| NCI-2024-02978 | REGISTRY | None | None |
| 23-012176 | OTHER | None | None |