Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369610
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-12
Brief Title:
Risk Stratified De-escalated Hormone Therapy with Radiation Therapy for the Treatment Prostate Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria Genetic Score and Biologic Imaging
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This phase II trial tests how well risk based de-escalated hormone therapy ie fewer treatments with radiation works in treating patients with prostate cancer Androgen deprivation therapy ADT such as gonadotropin-releasing hormone analogs LHRH and abiraterone acetate Zytiga lower the amount of the male hormone testosterone made by the body This may help kill or stop the growth of tumor cells that need testosterone to grow Radiation therapy uses high energy x-rays particles or radioactive seeds to kill cancer cells and shrink tumors Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer However there are few studies that determine ADT treatment based on risk factors Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer
Detailed Description:
PRIMARY OBJECTIVE
I Recovery of the Expanded Prostate Cancer Index Composite EPIC hormonal domain to baseline levels at 2-years
EXPLORATORY OBJECTIVES
I After completion of radiation therapy determine the incidence of
Ia Grade 2 or greater genitourinary GU and gastrointestinal GI toxicity at 6 months Common Terminology Criteria for Adverse Events CTCAE version 50 Ib Grade 3 or greater GU and GI toxicity at 6 months CTCAE version 50 Ic Patient-reported quality of life Id Impotence after the use of radiation therapy at 3 years Ie Freedom from biochemical failure FFBF at 5 years If Clinical failure local andor distant at 5 years Ig Salvage androgen deprivation use SAD at 5 years Ih Progression free survival using clinical biochemical and SAD as events at 5 years Ij Overall survival at 5 years Ik Disease-specific survival at 5 years II Determine overall GI and GU toxicity
OUTLINE Patients are assigned to 1 of 3 risk groups
GROUP I LOW RISK Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks
GROUP II INTERMEDIATE RISK Patients receive ADT subcutaneously SC or intramuscularly IM for up to 12 months in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy
GROUP III HIGH RISK Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy
Additionally patients undergo positron emission tomography PET computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the trial
After completion of study treatment patients are followed up at months 3 and 12 then yearly for up to year 5 followed by every 2 years
I Recovery of the Expanded Prostate Cancer Index Composite EPIC hormonal domain to baseline levels at 2-years
EXPLORATORY OBJECTIVES
I After completion of radiation therapy determine the incidence of
Ia Grade 2 or greater genitourinary GU and gastrointestinal GI toxicity at 6 months Common Terminology Criteria for Adverse Events CTCAE version 50 Ib Grade 3 or greater GU and GI toxicity at 6 months CTCAE version 50 Ic Patient-reported quality of life Id Impotence after the use of radiation therapy at 3 years Ie Freedom from biochemical failure FFBF at 5 years If Clinical failure local andor distant at 5 years Ig Salvage androgen deprivation use SAD at 5 years Ih Progression free survival using clinical biochemical and SAD as events at 5 years Ij Overall survival at 5 years Ik Disease-specific survival at 5 years II Determine overall GI and GU toxicity
OUTLINE Patients are assigned to 1 of 3 risk groups
GROUP I LOW RISK Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks
GROUP II INTERMEDIATE RISK Patients receive ADT subcutaneously SC or intramuscularly IM for up to 12 months in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy
GROUP III HIGH RISK Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy
Additionally patients undergo positron emission tomography PET computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the trial
After completion of study treatment patients are followed up at months 3 and 12 then yearly for up to year 5 followed by every 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03020 | REGISTRY | None | None |
| 22-012591 | OTHER | None | None |
| GMROA2256 | OTHER | Mayo Clinic in Arizona | None |