Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA)
| Group | Value (years) |
|---|---|
| Intermittent Androgen Suppression (IAS) | 4.0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name IAS
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation. Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became metastatic, became castrate resistant, or withdrew from the study. Subjects were monitored for time to development of Castration Resistant Prostate Cancer (CRPC) and overall survival. They were also monitored for the impact of IAS on a variety of neuro-psychiatric assessments and on bone density.
Experimental
Intermittent Androgen Suppression (IAS)
Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate. Flutamide dosed as 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate. Leuprolide Acetate dosed as 7.5mg intramuscular (IM) injections once per month for a total of 9 months.
Outcomes the sponsor listed as primary.
Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA)
Time frame · From date of first treatment until the date of development of CR, metastatic progression, or study withdrawal, whichever came first, assessed up to 16 years.
Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels \<50 ng/dL.
Effect of IAS on Overall Survival.
Time frame · From date of first treatment until the date of death or study withdrawal, whichever came first, assessed up to 16 years.
Assessment of overall survival measured as median time from completion of first full cycle of IAS until date of death from any cause.
Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS
Time frame · From screening prior to first dose of ADT through the start of the second cycle of ADT.
Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health for each patient at each time point.
Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS
Time frame · From screening prior to first dose of ADT through the start of the second cycle of ADT.
Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health. Percent change was assess for each patient at each time point.
Development of Osteopenia (Bone Loss) During IAS
Time frame · From screening prior to first dose of ADT through the start of the second cycle of ADT.
Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health for each patient at each time point. This measure was defined as the percentage of participants with normal BMD scores at baseline who developed Osteopenia after the first cycle of ADT.
Testosterone Levels During IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Testosterone was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.
Estradiol Levels During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Estradiol was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.
Score on Spatial Ability Test (Block Design) During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Spatial Ability was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Wechsler Adult Intelligence Scale-Revised, Block Design sub-test and measures participants' ability to analyze and construct abstract figures from their component parts. The test allows a time limit of 3 minutes per design, for a total of nine designs. Score is based on total number of designs completed (max 9, min 0).
Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Spatial Ability (Mental Rotation) was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Vandenberg \& Kuse (1978) Mental Rotation Test. Subjects are presented with line drawings of complex, three dimensional cubes on a computer screen. The subject must compare the two drawings and decide if they match. Score is based on number of correctly identified figures.
Score on Executive Function Testing (Stroop Task) During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Executive Function was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This assessment was based on the Stroop Color Word Interference Task. Subjects are asked to read 100 color words (red, green, blue), followed by identification of color blocks followed by reading the color of the ink and ignoring the word (e.g., the word 'blue' printed in green letters). Assessment was based on the amount of time needed to time to complete the assessment.
Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via the Proactive Interference (PI) task. The PI task involves participants listening to a list of 10 words from the same semantic category (e.g., articles of clothing), and then recalling as many of these words as possible.The procedure is repeated for a total of 4 trials. Assessment is based on the total number of words recalled.
Score on Visual Working Memory Test During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Visual Working Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. This task is based on the Subject Ordered Pointing Task (SOPT). The participant is shown a grid array of 10, 12 or 16 abstract designs and they must choose a new design with each refresh of the screen. Assessment is based on total number of errors.
Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Verbal Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT via Story Recall. This task is based on the well known Wechsler Memory Scale -Revised Logical Memory task. Participants listened to two brief narratives (stories) and were asked to recall as much as possible immediately after hearing each story and following a 20-minute delay. Assessment was based on number of correctly recalled pieces of information after a delay.
Score on Spatial Memory Testing During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Spatial Memory was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT using the Puget Sound Route Learning Test. This test measured the ability to navigate a short route within a room. Three trials were administered followed by three trials of a new route using pictures placed on the floor as landmarks. A delayed recall is administered after twenty minutes. Performance was assessed based on number of correctly recalled sequences after a delay.
Score on Verbal Ability/Fluency Testing During First Cycle of IAS
Time frame · Baseline, Month 3, Month 9, and Month 12
Verbal Ability/Fluency was assessed at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT. Participants were asked to verbally generate as many words beginning with a particular letter (e.g. P) within a 60 second period. Two trials were administered with two different letters. The total number of words generated was recorded for each letter and summed and analyzed.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (years) |
|---|---|
| Intermittent Androgen Suppression (IAS) | 4.0 |
| Group | Value (years) |
|---|---|
| Intermittent Androgen Suppression (IAS) | 6.6 |
| Group | Value (Percent change in BMD) |
|---|---|
| Intermittent Androgen Suppression (IAS) | -3.4 |
| Group | Value (Percent change of BMD) |
|---|---|
| Intermittent Androgen Suppression (IAS) | -1.2 |
| Group | Value (percent of participants) |
|---|---|
| Intermittent Androgen Suppression (IAS) | 13.2 |
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Intermittent Androgen Suppression (IAS) | 406 | 1.6 |
| Group | Value (pg/ml) | Spread |
|---|---|---|
| Intermittent Androgen Suppression (IAS) | 33.60 | 17.29 |
| Group | Value (Number of correctly completed designs) | Spread |
|---|---|---|
| Combined Androgen Blockade | 8.65 | 0.81 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Combined Androgen BlockadeIntermittent Hormone Therapy using Flutamide and Leuprolide acetate Flutamide: 250mg three times a day by mouth Leuprolide Acetate: 7.5mg once a month by intramuscular injection | 33 / 102 | 5 / 102 | 91 / 102 |
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.
1 study on this page
Indexing hint: Clinical trial · 2015
Kuo et al. 2015Clinical genitourinary cancercited by 12
PMID 25242417PMC4289425DOI 10.1016/j.clgc.2014.08.003PUB-25242417
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