Time to Treatment Failure
| Group | Value (months) |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 42.1 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 17.0 |
Trial · Interventional
Active, not recruitingPhase 2Results postedRegistry dataUnited States
1 trial · 1 ongoing · 1 with posted results
Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
NCT0336173529 Aug 2018 to est. 6 Jan 2027
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase 2 trial studies radium Ra 223 dichloride, hormone therapy and stereotactic body radiation in treating patients with prostate cancer that has spread to other places in the body. Radium Ra 223 dichloride contains a radioactive substance that collects in the bone and gives off radiation that may kill cancer cells. Hormone therapy using leuprolide acetate or goserelin acetate may fight prostate cancer by lowering the amount of testosterone the body makes. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving radium Ra 223 dichloride, hormone therapy and stereotactic body radiation may work better at treating prostate cancer.
Experimental
Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)
Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.
Outcomes the sponsor listed as primary.
Time to Treatment Failure
Time frame · Assessed up to 5 years
Defined as time from the initiation of androgen deprivation therapy (ADT) for metastatic disease until PSA increase to \> pre-ADT level or PSA \> 10 (whichever is smaller) or radiographic or clinical progression or resumption of ADT by physician's choice.
Objective Response Rate
Time frame · Up to 5 years
Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level \<0.04 (undetectable). Overall Response (OR) = CR + PR. Proportion of patients achieving CR or PR at course 8, day 1 (post 6 doses of radium Ra 223 dichloride) were reported.
Progression-free Survival
Time frame · From the initiation of ADT for metastatic disease until PSA progression or radiographic progression or death, assessed up to 5 years
Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA \>2 ng/mL.
Overall Survival
Time frame · From date of initiation of protocol treatment to date of death from any cause, assessed up to 5 years
Complete Response (CR) Rate Defined as the Proportion of Patients Achieving CR
Time frame · Up to 5 years
Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level \<0.04 (undetectable).
Duration of Response
Time frame · From documented response to recurrent or progressive disease is first met, assessed up to 5 years
Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.
Duration of Overall Complete Response
Time frame · From documented CR to recurrent/ progressive disease, assessed up to 5 years
Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.
Bone Specific Progression-free Survival
Time frame · Time to progression of bone specific disease over baseline, assessed up to 5 years
Progression will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA \>2 ng/mL.
Duration of Stable Disease
Time frame · Time from start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, assessed up to 5 years
Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.
Number of Participants With Adverse Events (AE) Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time frame · Up to 5 years
Toxicity will be graded. The highest AE grade per cycle will be reported in the electronic case report form (eCRF) from start of therapy until the end of treatment visit.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 42.1 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 17.0 |
| Group | Value (Participants) |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 0 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 0 |
| Group | Value (months) |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 42.1 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 17.8 |
| Group | Value (months) |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | NA |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | NA |
| Group | Value (Participants) |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 0 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 0 |
| Group | Value |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | not posted |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | not posted |
| Group | Value |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | not posted |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | not posted |
| Group | Value (months) |
|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | 34.3 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) | NA |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection | 1 / 6 | 0 / 6 | 6 / 6 |
| Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection | 5 / 18 | 0 / 18 | 18 / 18 |
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