Trial Outcomes & Findings for 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer (NCT NCT00859781)
NCT ID: NCT00859781
Last Updated: 2025-04-30
Results Overview
Subjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Baseline and 18 months after study drug administration
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
1. 177Lu-J591+Ketoconzole
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
177Lu-J591: 177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
|
2. 111In-J591 + Ketoconazole
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
111In-J591: 111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
17
|
|
Overall Study
COMPLETED
|
38
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
1. 177Lu-J591+Ketoconzole
n=38 Participants
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
177Lu-J591: 177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
|
2. 111In-J591 + Ketoconazole
n=17 Participants
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
111In-J591: 111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
17 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 18 months after study drug administrationSubjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration.
Outcome measures
| Measure |
1. 177Lu-J591+Ketoconzole
n=38 Participants
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
177Lu-J591: 177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
|
2. 111In-J591 + Ketoconazole
n=17 Participants
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
111In-J591: 111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
|
|---|---|---|
|
Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration
|
0.50 proportion of participants
|
0.24 proportion of participants
|
SECONDARY outcome
Timeframe: Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 monthsPSA response will be determined by comparing the PSA levels after therapy to the baseline and pre-treatment PSA via blood specimens
Outcome measures
Outcome data not reported
Adverse Events
1. 177Lu-J591+Ketoconzole
Serious events: 2 serious events
Other events: 36 other events
Deaths: 13 deaths
2. 111In-J591 + Ketoconazole
Serious events: 0 serious events
Other events: 16 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
1. 177Lu-J591+Ketoconzole
n=38 participants at risk
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
177Lu-J591: 177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
|
2. 111In-J591 + Ketoconazole
n=17 participants at risk
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
111In-J591: 111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
|
|---|---|---|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Number of events 1 • 12 years
|
0.00%
0/17 • 12 years
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • Number of events 1 • 12 years
|
0.00%
0/17 • 12 years
|
Other adverse events
| Measure |
1. 177Lu-J591+Ketoconzole
n=38 participants at risk
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
177Lu-J591: 177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
|
2. 111In-J591 + Ketoconazole
n=17 participants at risk
Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
Ketoconazole: Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)
Hydrocortisone: Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)
111In-J591: 111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment
|
|---|---|---|
|
Gastrointestinal disorders
Infection
|
15.8%
6/38 • 12 years
|
23.5%
4/17 • 12 years
|
|
Blood and lymphatic system disorders
ALT Increase
|
13.2%
5/38 • 12 years
|
35.3%
6/17 • 12 years
|
|
Blood and lymphatic system disorders
Anemia
|
55.3%
21/38 • 12 years
|
47.1%
8/17 • 12 years
|
|
Metabolism and nutrition disorders
Anorexia
|
23.7%
9/38 • 12 years
|
11.8%
2/17 • 12 years
|
|
General disorders
Any Pain
|
47.4%
18/38 • 12 years
|
41.2%
7/17 • 12 years
|
|
Blood and lymphatic system disorders
AST Increase
|
15.8%
6/38 • 12 years
|
35.3%
6/17 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.4%
7/38 • 12 years
|
52.9%
9/17 • 12 years
|
|
Hepatobiliary disorders
Bilirubin Increase
|
0.00%
0/38 • 12 years
|
17.6%
3/17 • 12 years
|
|
Gastrointestinal disorders
Constipation
|
21.1%
8/38 • 12 years
|
17.6%
3/17 • 12 years
|
|
Investigations
Creatinine Increase
|
15.8%
6/38 • 12 years
|
23.5%
4/17 • 12 years
|
|
Psychiatric disorders
Depression
|
13.2%
5/38 • 12 years
|
17.6%
3/17 • 12 years
|
|
Gastrointestinal disorders
Diarrhea
|
15.8%
6/38 • 12 years
|
47.1%
8/17 • 12 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.3%
10/38 • 12 years
|
23.5%
4/17 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Edema in Limbs
|
21.1%
8/38 • 12 years
|
23.5%
4/17 • 12 years
|
|
General disorders
Fatigue
|
55.3%
21/38 • 12 years
|
58.8%
10/17 • 12 years
|
|
Nervous system disorders
Headaches
|
15.8%
6/38 • 12 years
|
11.8%
2/17 • 12 years
|
|
Renal and urinary disorders
Hematuria
|
10.5%
4/38 • 12 years
|
5.9%
1/17 • 12 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.2%
5/38 • 12 years
|
0.00%
0/17 • 12 years
|
|
Psychiatric disorders
Insomnia
|
28.9%
11/38 • 12 years
|
11.8%
2/17 • 12 years
|
|
Investigations
Lymphocyte Count Decreased
|
23.7%
9/38 • 12 years
|
5.9%
1/17 • 12 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
19/38 • 12 years
|
11.8%
2/17 • 12 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremities
|
26.3%
10/38 • 12 years
|
23.5%
4/17 • 12 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
4/38 • 12 years
|
5.9%
1/17 • 12 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
68.4%
26/38 • 12 years
|
17.6%
3/17 • 12 years
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
4/38 • 12 years
|
11.8%
2/17 • 12 years
|
|
Investigations
WBC Decreased
|
26.3%
10/38 • 12 years
|
5.9%
1/17 • 12 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place