Trial · Interventional
Active, not recruitingPhase 2/3Registry dataAntiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
Overview
- Status
- Active, not recruiting
- Phase
- Phase 2/3
- Enrollment
- 612 participants (actual)
- Sponsor
- NRG Oncology · Other
- Design
- Randomized · Open label (no masking)
- Countries
3 countries
United States, Canada, Puerto Rico
- Start
- 5 Apr 2017
- Primary completion
- 31 Oct 2025
- Completion
- 31 Oct 2030 (estimated)
- First posted
- 6 Mar 2017
- Last update posted
- 14 Sept 2026
- Conditions
- Stage I Prostate Adenocarcinoma AJCC v7 · Stage II Prostate Adenocarcinoma AJCC v7 · Stage III Prostate Adenocarcinoma AJCC v7
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2/3
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
NCT030708865 Apr 2017 to est. 31 Oct 2030
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
Interventions
- BicalutamideDrug
- DegarelixDrug
- DocetaxelDrug
- External Beam Radiation TherapyRadiation
- FlutamideDrug
- GoserelinDrug
- Goserelin AcetateDrug
- Laboratory Biomarker AnalysisOther
- LeuprolideDrug
- Leuprolide AcetateDrug
- NilutamideDrug
Arms2
Active comparator
Arm I (androgen deprivation therapy, EBRT)
Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.
Experimental
Arm II (androgen deprivation therapy, EBRT, docetaxel)
Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV over 1 hour on day 1 of every 21 days for 6 cycless in the absence of disease progression or unexpected toxicity.
Primary outcomes2
Outcomes the sponsor listed as primary.
Freedom from progression (FFP) (Phase II)
Time frame · From time of randomization to first event, assessed up to 43 months
Registry description
Will be determined with a one-sided stratified log-rank test when 89 FFP events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. Events for FFP will be the first occurrence of biochemical failure by prostate specific antigen (PSA) \>= 0.4 ng/ml over the nadir PSA confirmed by a second PSA higher than the first by any amount, recurrence (local, regional or distant), institution of secondary androgen deprivation therapy and death from any cause.
Metastasis free survival (MFS) (Phase III)
Time frame · From time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years
Registry description
Will be measured with a one-sided stratified log-rank test when 282 MFS events have been observed. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
Secondary outcomes(6)
Overall survival
Time frame · Time to death from any cause assessed up to 2.5 years
Registry description
Will be analyzed using log-rank methodology and Cox proportional models. Tests for violations of proportionality will performed for the survival models. Fine and Gray's regression also will be used. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
Time to local progression
Time frame · Baseline to local or regional recurrence ignoring biochemical failure and distant recurrence and censoring for death, assessed up to 2.5 years
Registry description
Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
Proportion of undetectable prostate specific antigen (PSA) with a non-castrate testosterone
Time frame · At 2.5 years
Registry description
Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
Incidence of acute adverse events scored according to the Cancer Therapy Evaluation Program active version of the Common Terminology Criteria for Adverse Events
Time frame · Up to 30 days post radiation therapy
Registry description
Will be compared to late grade 3+ adverse events. Univariate logistic regression will be used to model the distribution of acute adverse events. Multiple logistic regression will be used to model the distribution of acute adverse events adjusted for covariates. Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed and tested using a one-sided Chi-Square test statistic with the significance level of 0.025. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
Genomic profiling in making adjuvant therapy decisions
Time frame · Up to 9 years
Registry description
Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed.
Late grade 3+ adverse events scored according to the Cancer Therapy Evaluation Program active version of the Common Terminology Criteria for Adverse Events
Time frame · From protocol treatment starts to the worst late grade 3+ adverse event, assessed up to 9 years
Registry description
Will be compared to acute adverse events. A Fine and Gray's regression model will be used to compare the treatment differences of time to late adverse event with and without adjusting for other covariates. Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed and tested using a one-sided. Will be estimated using the cause-specific hazard rate approach and tested using a significance level of 0.025. Both unadjusted and adjusted hazard ratios and the respective 95% confidence interval will be computed. At least the treatment arm, age, and race (as appropriate) will be considered when it is adjusted in the analysis.
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
PepBank is a research reference. Talk to a doctor before you use any peptide.