Biochemical Progression-free Survival Rate
| Group | Value |
|---|---|
| Androgen Deprivation Therapy | not posted |
| No Androgen Deprivation Therapy | not posted |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
NCT00937768Jul 2009 to Jul 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This randomized phase II trial studies the side effects and how well giving leuprolide acetate or goserelin acetate works compared to observation in treating patients with high-risk prostate cancer who have undergone radical prostatectomy. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin acetate and leuprolide acetate, may lessen the amount of androgens made by the body and thus control prostate cancer growth. Many times, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. However, in some prostate cancers there is a chance that tumors can re-grow despite surgery based on certain high risk features.
Experimental
Arm A (antihormone therapy)
Patients receive leuprolide acetate IM on day 1 OR goserelin acetate SC on day 1. Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.
No intervention
Arm B (no antihormone therapy)
Patients undergo observation every 3 months for 9 months.
Outcomes the sponsor listed as primary.
Biochemical Progression-free Survival Rate
Time frame · 2 years
Biochemical progression-free survival (BPFS) was defined as the time from randomization to the time of biochemical progression. If a patient dies without a documentation of biochemical progression, the patient will be considered to have had progressed at the time of death.
Number of Deaths
Time frame · 2 years
The number of deaths due to any cause are reported below.
Percentage of Participants With Grade 3 or Higher Adverse Events Regardless of Attribution
Time frame · 2 years
Percentage of Participants with Grade 3 or Higher Adverse Events regardless of attribution per NCI CTCAE Version 3
Average Overall FACT-P Total Score at Baseline, Months 3 and 6
Time frame · Baseline and months 3 and 6
The overall FACT-P Total Score at Baseline and months 3 and 6 mean and standard deviations are reported below. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.
Average LASA Overall Quality of Life at Baseline, Months 3 and 6
Time frame · Baseline to Months 3 and 6
LASA Overall Quality of Life at Baseline, Months 3 and 6. Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The average and standard deviation of the LASA overall quality of life score are reported below at baseline, months 3 and 6.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Androgen Deprivation Therapy | not posted |
| No Androgen Deprivation Therapy | not posted |
| Group | Value (Participants) |
|---|---|
| Androgen Deprivation Therapy | 0 |
| No Androgen Deprivation Therapy | 0 |
| Group | Value (percentage of patients) |
|---|---|
| Androgen Deprivation Therapy | 100 |
| No Androgen Deprivation Therapy | 37.5 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Androgen Deprivation Therapy | 122.7 | 5.9 |
| No Androgen Deprivation Therapy | 114.8 | 16.92 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Androgen Deprivation Therapy | 8.8 | 0.75 |
| No Androgen Deprivation Therapy | 6.9 | 1.77 |
| Group | Value |
|---|---|
| Androgen Deprivation Therapy | not posted |
| No Androgen Deprivation Therapy | not posted |
| Group | Value |
|---|---|
| Androgen Deprivation Therapy | not posted |
| No Androgen Deprivation Therapy | not posted |
| Group | Value |
|---|---|
| Androgen Deprivation Therapy | not posted |
| No Androgen Deprivation Therapy | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Androgen Deprivation TherapyPatients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1. | 0 / 8 | 0 / 8 | 8 / 8 |
| No Androgen Deprivation TherapyPatients undergo observation every 3 months for 9 months. | 0 / 8 | 1 / 8 | 6 / 8 |
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.
No study cites this trial.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated