Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:02 AM
Study NCT ID:
NCT05241860
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
A Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer (MHSPC): A-DREAM
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
A-DREAM
Brief Summary:
This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to \>= 150 ng/ml) after treatment interruption.
SECONDARY OBJECTIVES:
I. To determine time to eugonadal testosterone (\> 150 ng/dl). II. To determine duration off-treatment.
III. To assess changes in quality of life as follows:
1. To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score from baseline to 24 months after treatment interruption.
2. To assess changes in the FACT-P subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to 24 months after treatment interruption.
3. To assess changes in the FACT-P total score and subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to the remaining post-baseline time points (i.e., 6, 12, and 18 months) after treatment interruption.
OUTLINE:
Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in prostate specific antigen (PSA) level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.
After completion of study treatment, patients are followed up every 6 months for 10 years from registration or withdrawal from the study or death.
I. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to \>= 150 ng/ml) after treatment interruption.
SECONDARY OBJECTIVES:
I. To determine time to eugonadal testosterone (\> 150 ng/dl). II. To determine duration off-treatment.
III. To assess changes in quality of life as follows:
1. To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score from baseline to 24 months after treatment interruption.
2. To assess changes in the FACT-P subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to 24 months after treatment interruption.
3. To assess changes in the FACT-P total score and subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to the remaining post-baseline time points (i.e., 6, 12, and 18 months) after treatment interruption.
OUTLINE:
Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in prostate specific antigen (PSA) level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.
After completion of study treatment, patients are followed up every 6 months for 10 years from registration or withdrawal from the study or death.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA180821 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2021-13974 | REGISTRY | NCI Clinical Trial Reporting Program | View |