Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)
| Group | Value (Participants) |
|---|---|
| Experimental Arm | 20 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
NCT032980871 Jul 2018 to 31 Mar 2024
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.
Experimental
Experimental Arm
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
Outcomes the sponsor listed as primary.
Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)
Time frame · 6 months after recovery of testosterone
PSA is a biomarker for disease burden in prostate adenocarcinoma and offers a non-invasive and sensitive assessment of disease control after treatment in the vast majority of patients.
Time to Biochemical Progression
Time frame · up to 5 years
biochemical, radiographic, or clinical
Time to Radiographic Progression
Time frame · up to 5 years
per PCWG3 criteria
Time to Initiation of Additional Antineoplastic Therapy
Time frame · up to 5 years
antineoplastic therapy includes any systemic or focal anti-prostate cancer therapy
Prostate Cancer Specific Survival
Time frame · up to 5 years
Prostate cancer specific survival
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire
Time frame · Every 3 months up to a total of 21 months
This uses the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. It assesses patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Items are rated on a 0 to 4 Likert type scale and combined to produce sub-scores that are summed into a total FACT-P score, the higher the score, the better the quality of life. Range from 0-150 . Data was aggregated per patient and over time. Data represented here are the mean scores and 95% confidence intervals of the participants who filled out the questionnaire (15/24 completed through 18 months, 12/24 completed through 21 months).
Number of Participants With Treatment-related Adverse Events as Assessed by Physician Using CTCAE v4.0 Criteria
Time frame · up to 5 years
CTCAE v4 criteria are a set of criteria for the standardized classification of adverse effects cancer therapy. The CTCAE system is a product of the US National Cancer Institute. The criteria are assessed by physician. The grades range from 0 to 5 (higher is worse). Data will be aggregated per patient and over time and classified by organ system (e.g., genitourinary, gastrointestinal, etc).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Experimental Arm | 20 |
| Group | Value (months) |
|---|---|
| Experimental Arm | NA |
| Group | Value (months) |
|---|---|
| Experimental Arm | NA |
| Group | Value (months) |
|---|---|
| Experimental Arm | NA |
| Group | Value (percentage of participants) |
|---|---|
| Experimental Arm | 100 |
| Group | Value (Score on a Scale) |
|---|---|
| Experimental Arm | 118 |
| Group | Value (Participants) |
|---|---|
| Experimental Arm | 19 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Experimental ArmRadical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy. radical prostatectomy: surgical removal of the prostate stereotactic body radiotherapy: Highly targeted radiation Leuprolide: Lowers serum testosterone apalutamide: antiandrogen abiraterone: Inhibits androgen synthesis | 0 / 28 | 1 / 28 | 21 / 28 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
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References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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