Trial Outcomes & Findings for Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer (NCT NCT00328614)
NCT ID: NCT00328614
Last Updated: 2025-05-16
Results Overview
To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT). Dose levels: Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
5 months (1 month HT, administration of drug, 4 months HT and RT)
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
Samarium-153 (0.25 mCi/kg)
Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (0.5 mCi/kg)
Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (0.75 mCi/kg)
Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (1.0 mCi/kg)
Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (1.5 mCi/kg)
Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (2.0 mCi/kg)
Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
6
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Samarium-153 (0.25 mCi/kg)
n=4 Participants
Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (0.5 mCi/kg)
n=4 Participants
Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (0.75 mCi/kg)
n=6 Participants
Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (1.0 mCi/kg)
n=6 Participants
Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (1.5 mCi/kg)
n=6 Participants
Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (2.0 mCi/kg)
n=6 Participants
Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Total
n=32 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Age, Continuous
|
66.97 years
STANDARD_DEVIATION 1.37 • n=5 Participants
|
65.10 years
STANDARD_DEVIATION 9.78 • n=7 Participants
|
65.58 years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
69.46 years
STANDARD_DEVIATION 8.04 • n=4 Participants
|
68.00 years
STANDARD_DEVIATION 13.13 • n=21 Participants
|
66.19 years
STANDARD_DEVIATION 8.02 • n=8 Participants
|
66.99 years
STANDARD_DEVIATION 8.75 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
32 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 5 months (1 month HT, administration of drug, 4 months HT and RT)To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT). Dose levels: Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose.
Outcome measures
| Measure |
Samarium-153
n=29 Participants
Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
|---|---|
|
Maximum Tolerated Dose of Samarium-153
|
2.0 mCi/kg
|
Adverse Events
Samarium-153 (0.25 mCi/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Samarium-153 (0.5 mCi/kg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Samarium-153 (0.75 mCi/kg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Samarium-153 (1.0 mCi/kg)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Samarium-153 (1.5 mCi/kg)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Samarium-153 (2.0 mCi/kg)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Samarium-153 (0.25 mCi/kg)
n=4 participants at risk
Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (0.5 mCi/kg)
n=4 participants at risk
Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (0.75 mCi/kg)
n=6 participants at risk
Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (1.0 mCi/kg)
n=5 participants at risk
Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (1.5 mCi/kg)
n=5 participants at risk
Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
Samarium-153 (2.0 mCi/kg)
n=6 participants at risk
Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
83.3%
5/6 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
40.0%
2/5 • Number of events 2
|
66.7%
4/6 • Number of events 4
|
|
Blood and lymphatic system disorders
Blood/bone marrow
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
66.7%
4/6 • Number of events 4
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
60.0%
3/5 • Number of events 4
|
83.3%
5/6 • Number of events 5
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Libido decreased
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Urine color changed
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Abdominal pain and cramping
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Hot flashes/flushes
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Urinary incontinence
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place