Trial · Interventional
RecruitingPhase 3Registry dataStandard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 1,273 participants (estimated)
- Sponsor
- SWOG Cancer Research Network · Network
- Design
- Randomized · Open label (no masking)
- Countries
5 countries
United States, Chile, Colombia, Mexico, Switzerland
- Start
- 24 Sept 2018
- Primary completion
- 1 Apr 2033 (estimated)
- Completion
- 1 Oct 2036 (estimated)
- First posted
- 19 Sept 2018
- Last update posted
- 8 Oct 2026
- Conditions
- Castration Levels of Testosterone · Metastatic Prostatic Adenocarcinoma · Stage IV Prostate Cancer AJCC v8 · Stage IVA Prostate Cancer AJCC v8 · Stage IVB Prostate Cancer AJCC v8
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT0367802524 Sept 2018 to est. 1 Oct 2036
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
Interventions
- AbirateroneDrug
- BicalutamideDrug
- DegarelixDrug
- DocetaxelDrug
- FlutamideDrug
- Goserelin AcetateDrug
- Histrelin AcetateDrug
- Leuprolide AcetateDrug
- NilutamideDrug
- OrchiectomyProcedure
- PrednisoneDrug
- Quality-of-Life AssessmentOther
- Radiation TherapyRadiation
- Radical ProstatectomyProcedure
- TriptorelinDrug
Arms3
Active comparator
Arm I (SST)
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
Experimental
Arm II (SST, prostatectomy or radiation therapy)
Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
Active comparator
Step 1 (pre-randomization)
Standard treatment data collection prior to randomization
Primary outcomes1
Outcomes the sponsor listed as primary.
Overall survival (OS)
Time frame · From date of randomization to date of death due to any cause, assessed up to 8 years
Secondary outcomes(3)
Media OS
Time frame · From date of randomization to date of death due to any cause, assessed up to 8 years
Registry description
Will compare OS in metastatic prostate cancer patients who received standard systemic therapy (SST) plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.
Rate of symptomatic local progression
Time frame · Up to 8 years
Registry description
Defined as any of the following events post-randomization: Common Terminology Criteria for Adverse Events version 5 grade \>= 2 hematuria, urinary retention, urinary tract obstruction, urinary tract pain, pelvic pain, renal and urinary disorders-other. Will be compared between the treatment arms. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.
Progression-free survival (PFS)
Time frame · From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years
Registry description
Will be compared between for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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