Trial Outcomes & Findings for Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) (NCT NCT05241860)
NCT ID: NCT05241860
Last Updated: 2026-08-31
Results Overview
The proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to \>= 150 ng/ml) after treatment interruption will be calculated for the study cohort.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
At 18 months
Results posted on
2026-08-31
Participant Flow
Participant milestones
| Measure |
Treatment (Discontinue Hormonal Medication, Follow up)
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 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.\> \> Pharmacotherapy Discontinuation: Stop hormonal medications (Abiraterone, Enzalutamide, Apalutamide, Leuprolide, Goserelin, Degarelix, Relugolix)\>
\> Follow-Up: Undergo follow-up\>
\> Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
Baseline characteristics by cohort
| Measure |
Treatment (Discontinue Hormonal Medication, Follow up)
n=78 Participants
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 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.\> \> Pharmacotherapy Discontinuation: Stop hormonal medications (Abiraterone, Enzalutamide, Apalutamide, Leuprolide, Goserelin, Degarelix, Relugolix)\>
\> Follow-Up: Undergo follow-up\>
\> Questionnaire Administration: Ancillary studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Age, Continuous
|
70 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: At 18 monthsThe proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to \>= 150 ng/ml) after treatment interruption will be calculated for the study cohort.
Outcome measures
| Measure |
Treatment (Discontinue Hormonal Medication, Follow up)
n=78 Participants
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 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.
\>
\> Pharmacotherapy Discontinuation: Stop hormonal medications (Abiraterone, Enzalutamide, Apalutamide, Leuprolide, Goserelin, Degarelix, Relugolix)
\>
\> Follow-Up: Undergo follow-up
\>
\> Questionnaire Administration: Ancillary studies
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Treatment-free With Eugonadal Testosterone (>= 150 ng/dl)
|
0.410 proportion of participants
Interval 0.331 to 0.489
|
SECONDARY outcome
Timeframe: Up to 10 yearsThe median time to eugonadal testosterone (\> 150 ng/dl) will be computed by the cumulative incidence function.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 yearsThe median time off-treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 yearsThe median time to radiographic progression or death (whichever occurs first) will be computed by the Kaplan-Meier estimator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsThe median time to the first subsequent treatment will be computed by the cumulative incidence function.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 10 yearsThe median survival time will be computed by the Kaplan-Meier estimator. Survival time defined as from treatment interruption per protocol to death due to any cause or censored at date last known alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 10 yearsThe median survival time will be computed by the cumulative incidence function. Cancer-specific survival as defined as from treatment interruption per protocol to death attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 yearsThe median survival time will be computed by the cumulative incidence function. Non-cancer-specific survival as defined as from treatment interruption per protocol to death not attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed up to 10 yearsThe median PSA progression free survival time will be computed by the Kaplan-Meier estimator. PSA progression free survival as defined as from treatment interruption per protocol to the first PSA failure (two consecutive increases in PSA of 25% and \>= 2 ng/mL above nadir) or death.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Discontinue Hormonal Medication, Follow up)
Serious events: 4 serious events
Other events: 78 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (Discontinue Hormonal Medication, Follow up)
n=79 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
General disorders and administration site conditions
Death NOS
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
Other adverse events
| Measure |
Treatment (Discontinue Hormonal Medication, Follow up)
n=79 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Endocrine disorders
Hyperthyroidism
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Endocrine disorders
Hypothyroidism
|
1.3%
1/79 • Number of events 12 • Up to 18 months
|
|
Eye disorders
Eye disorders - Other, specify
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Eye disorders
Retinal tear
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
2/79 • Number of events 2 • Up to 18 months
|
|
Gastrointestinal disorders
Bloating
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/79 • Number of events 5 • Up to 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
3/79 • Number of events 5 • Up to 18 months
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.1%
4/79 • Number of events 4 • Up to 18 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Gastrointestinal disorders
Toothache
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
General disorders and administration site conditions
Edema limbs
|
7.6%
6/79 • Number of events 17 • Up to 18 months
|
|
General disorders and administration site conditions
Edema trunk
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
General disorders and administration site conditions
Facial pain
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
General disorders and administration site conditions
Fatigue
|
86.1%
68/79 • Number of events 414 • Up to 18 months
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
General disorders and administration site conditions
Pain
|
11.4%
9/79 • Number of events 49 • Up to 18 months
|
|
Infections and infestations
Bronchial infection
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Infections and infestations
Herpes simplex reactivation
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Infections and infestations
Lung infection
|
3.8%
3/79 • Number of events 3 • Up to 18 months
|
|
Infections and infestations
Pharyngitis
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Infections and infestations
Sinusitis
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Injury, poisoning and procedural complications
Burn
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
3/79 • Number of events 4 • Up to 18 months
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
3/79 • Number of events 3 • Up to 18 months
|
|
Investigations
Alkaline phosphatase increased
|
5.1%
4/79 • Number of events 12 • Up to 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
2/79 • Number of events 2 • Up to 18 months
|
|
Investigations
Creatinine increased
|
3.8%
3/79 • Number of events 6 • Up to 18 months
|
|
Investigations
Investigations - Other, specify
|
2.5%
2/79 • Number of events 6 • Up to 18 months
|
|
Investigations
Lymphocyte count decreased
|
3.8%
3/79 • Number of events 7 • Up to 18 months
|
|
Investigations
Platelet count decreased
|
5.1%
4/79 • Number of events 5 • Up to 18 months
|
|
Investigations
Thyroid stimulating hormone increased
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Investigations
Weight gain
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Investigations
Weight loss
|
2.5%
2/79 • Number of events 4 • Up to 18 months
|
|
Investigations
White blood cell decreased
|
2.5%
2/79 • Number of events 7 • Up to 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
1/79 • Number of events 5 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.8%
3/79 • Number of events 13 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.5%
2/79 • Number of events 2 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
5.1%
4/79 • Number of events 6 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.5%
2/79 • Number of events 4 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
4/79 • Number of events 10 • Up to 18 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
4/79 • Number of events 10 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.5%
2/79 • Number of events 11 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.5%
13/79 • Number of events 31 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.3%
1/79 • Number of events 6 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.5%
2/79 • Number of events 3 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.5%
2/79 • Number of events 2 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/79 • Number of events 5 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
4/79 • Number of events 7 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.5%
2/79 • Number of events 8 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
5/79 • Number of events 20 • Up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Nervous system disorders
Cognitive disturbance
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Nervous system disorders
Depressed level of consciousness
|
1.3%
1/79 • Number of events 4 • Up to 18 months
|
|
Nervous system disorders
Dizziness
|
1.3%
1/79 • Number of events 11 • Up to 18 months
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Nervous system disorders
Paresthesia
|
2.5%
2/79 • Number of events 5 • Up to 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Nervous system disorders
Syncope
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Psychiatric disorders
Anxiety
|
2.5%
2/79 • Number of events 3 • Up to 18 months
|
|
Psychiatric disorders
Confusion
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Psychiatric disorders
Depression
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Psychiatric disorders
Insomnia
|
5.1%
4/79 • Number of events 14 • Up to 18 months
|
|
Psychiatric disorders
Libido decreased
|
88.6%
70/79 • Number of events 460 • Up to 18 months
|
|
Psychiatric disorders
Libido increased
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Renal and urinary disorders
Hematuria
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Renal and urinary disorders
Urinary frequency
|
3.8%
3/79 • Number of events 17 • Up to 18 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
2/79 • Number of events 7 • Up to 18 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Renal and urinary disorders
Urinary urgency
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Reproductive system and breast disorders
Breast pain
|
1.3%
1/79 • Number of events 2 • Up to 18 months
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
88.6%
70/79 • Number of events 563 • Up to 18 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
2.5%
2/79 • Number of events 4 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
2/79 • Number of events 4 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
3/79 • Number of events 6 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
2/79 • Number of events 6 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.5%
2/79 • Number of events 4 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.3%
1/79 • Number of events 3 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.3%
1/79 • Number of events 8 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.8%
3/79 • Number of events 7 • Up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Vascular disorders
Hot flashes
|
82.3%
65/79 • Number of events 356 • Up to 18 months
|
|
Vascular disorders
Hypertension
|
16.5%
13/79 • Number of events 65 • Up to 18 months
|
|
Vascular disorders
Lymphedema
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Vascular disorders
Thromboembolic event
|
2.5%
2/79 • Number of events 7 • Up to 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
16.5%
13/79 • Number of events 46 • Up to 18 months
|
|
Cardiac disorders
Atrial fibrillation
|
7.6%
6/79 • Number of events 6 • Up to 18 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.1%
4/79 • Number of events 4 • Up to 18 months
|
|
Cardiac disorders
Chest pain - cardiac
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Cardiac disorders
Palpitations
|
1.3%
1/79 • Number of events 1 • Up to 18 months
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
2.5%
2/79 • Number of events 4 • Up to 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place