Phase 3
N=921
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Hormone Refractory Prostate Cancer · Bone Metastases
Bottom Line
View on ClinicalTrials.gov: NCT00699751 ↗Enrolled (actual)
921
Serious AEs
—
Results posted
May 2014
Primary outcome: Primary: Overall Survival — 14.9; 11.3 Months — p=0.00005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Radium-223 dichloride (Xofigo, BAY88-8223) (Drug); Placebo (Drug); Best standard of care (BSoC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bayer
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
14.9; 11.3 | 0.00005 sig |
| SECONDARY Time to Total Alkaline Phosphatase (ALP) Progression |
7.4; 3.8 | <0.00001 sig |
| SECONDARY Percentage of Participants With Total ALP Response at Week 12 |
59.4; 6.2; 32.6; 1.4; 47.1; 3.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) |
59.9; 4.5; 34.6; 1.7; 13.9; 1 | <0.001 sig |
| SECONDARY Percentage of Participants With Total ALP Normalization at Week 12 |
34; 1.4 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Total ALP at Week 12 |
-32.2; 37.2 | <0.001 sig |
| SECONDARY Maximum Percentage Decrease From Baseline in Total ALP up to Week 12 |
-38.9; -5.9 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) |
-29.9; 62.1 | <0.001 sig |
| SECONDARY Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment |
-44.4; -7.5 | <0.001 sig |
| SECONDARY Time to Prostate Specific Antigen (PSA) Progression |
3.6; 3.4 | <0.00001 sig |
| SECONDARY Percentage of Participants With PSA Response at Week 12 |
16.4; 6.2; 7.7; 4.3; 5.7; 1.9 | <0.001 sig |
| SECONDARY Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) |
14.2; 4.5; 9; 3.1; 6.1; 1.7 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in PSA at Week 12 |
83.3; 543.8 | 0.160 |
| SECONDARY Maximum Percentage Decrease From Baseline in PSA up to Week 12 |
-13.0; -7.8 | 0.004 sig |
| SECONDARY Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase) |
144.3; 191.1 | 0.009 sig |
| SECONDARY Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period |
-16.4; -9.3 | <0.001 sig |
| SECONDARY Time to First Skeletal Related Event (SRE) |
16.4; 8.1 | 0.00012 sig |
| SECONDARY Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms |
18; 10.7 | 0.00008 sig |
| SECONDARY Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms |
NA; NA | 0.00191 sig |
| SECONDARY Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral |
NA; NA | 0.53277 |
| SECONDARY Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention |
NA; NA | 0.89567 |
| SECONDARY Time to Occurrence of First Spinal Cord Compression |
NA; NA | 0.14486 |
| SECONDARY Time to Occurrence of First Start of Any Other Anti-cancer Treatment |
15.4; 12.7 | 0.00932 sig |
| SECONDARY Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline |
23.4; 18.4 | 0.00187 sig |
Summary
ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Known hormone refractory disease
- Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy
- No intention to use cytotoxic chemotherapy within the next 6 months
- Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion Criteria
- Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
- Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
- Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
- Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
- Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
- History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
Data sourced from ClinicalTrials.gov (NCT00699751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.