Prostate CancerPhase 2IASNCT00223665
Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer
A Phase 2 study testing Flutamide and Leuprolide Acetate in people with Prostate Cancer, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Flutamide and Leuprolide Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 1997to 6 Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate
- Clinical stage A2, B, C, D1
- Age: older than 21 years old
- Performance status of 0 or 1
- Pretreatment serum testosterone, normal range (or no clinical evidence of testosterone deficiency).
- If less than 30 months since completion of radiation therapy, biopsy of prostate suggested within 6 months of study entry. If more than or equal to 30 months since completion of radiation therapy, biopsy of prostate suggested within 1 year.
- Written informed consent.
Who cannot join
- Abnormal bone scan suggestive of metastatic osseous disease.
- Previous hormonal manipulation including orchiectomy or any medication with significant antiandrogenic activity (combined androgen suppression over 9 months, monotherapy antiandrogens, estrogens, ketoconazole). *Neoadjuvant androgen suppression therapy of less than or equal to 3 months is allowed, if this androgen suppression therapy was completed more than or equal to 1 year prior to study enrollment AND if the Testosterone level is within the normal ranges.
- Any systemic chemotherapy or curative radiotherapy within 6 months.
- Hepatic dysfunction:
- Total bilirubin greater than 2.0 mg/dl
- Aspartate transaminase (AST; SGOT) greater than 3 times the upper limit of normal range
Show all 12Show fewer
- Lactate dehydrogenase (LDH) greater than 3 times the upper limit of normal range).
- Renal dysfunction:
- Blood urea nitrogen (BUN) greater than 40 mg/dl
- Serum Creatinine greater than 2.0 mg/dl.
- History or presence of other malignancy within the last 5 years (except treated squamous/basal cell carcinoma of the skin or superficial bladder carcinoma).
- Hypersensitivity to flutamide or leuprolide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Prospective Study of Intermittent Androgen Suppression (IAS) in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy
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.
Read the detailed description
The standard first line treatment for men with early stage newly diagnosed localized prostate cancer is a surgical removal of the prostate, localized external beam radiation, brachytherapy, or a combination of surgery and radiation. In most patients Prostate Specific Antigen (PSA) levels will decline after these localized treatments, demonstrating a response to these therapies. However despite an initial response to localized treatment, some men will go on to later develop a rise in PSA levels, an indicator of Biochemical Relapsed Prostate Cancer (BRPC). For BRPC patients who have not yet developed metastasis, the standard treatment is Androgen Deprivation Therapy (ADT) to decrease levels of Testosterone, subsequently decreasing PSA levels. A low value for the PSA is more desirable as it may indicate no tumor growth.
ADT may be administered as a continuous treatment (Continuous Androgen Suppression, or CAS) or as intermittent treatment (Intermittent Androgen Suppression, or IAS). This treatment is continued until the development of Castration Resistant Prostate Cancer (CRPC), indicated by a rise in PSA despite ADT. Giving the hormone therapy intermittently (in cycles of treatment and off treatment periods) appears to delay the change of prostate cancer to a type of prostate cancer that resists hormone therapy, prolonging efficacy of ADT monotherapy. IAS may also decrease the impact of ADT on mental status.
This study evaluated the effect of intermittent androgen suppression on time to androgen independent progression (the development of castration resistant disease) and overall survival in men with localized prostate cancer. Subjects were also evaluated for the effects of intermittent androgen suppression on a variety of neuro-psychiatric assessments and on bone density.
The subjects in this study had a rising PSA value after definitive therapy either with radical prostatectomy or external beam irradiation for the treatment of prostate cancer. All subjects were males at or over the age of 21 years.
New subjects were introduced to this study protocol (along with other non-study treatment options) during a clinic visit with Dr. Higano or another sub-investigator. After informed consent was obtained, subjects underwent the following screening procedures before starting treatment: Bone density scan (DEXA), Technetium-99 bone scan, CT scan of the chest, abdomen, and pelvis, blood draw, and neuro-psychiatric assessments. Subjects then began androgen suppression with a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate. During the treatment, they had quarterly clinic visits and blood draws. Their PSA levels were monitored monthly, and if their PSA reached the appropriate nadir at by month 9, the androgen suppression was interrupted. At the end of each treatment cycle, subjects underwent another bone density test, blood draw, problem solving test, and neuro-psychiatric assessments.
During the "off treatment" phase, the subject will again had quarterly clinic visits, blood draws, and neuro-psychiatric assessments. PSA and testosterone were be monitored monthly. Once the PSA reached the appropriate threshold, the subject performed another set of screening procedures and resumed treatment for another 9 months. This cycle continued until the patient withdrew from the study, was taken off the study due to toxicities or the decision of the investigator, or until the treatment with IAS was no longer effective in controlling the prostate cancer. The neuro-psychiatric assessments were only performed during the subject's first cycle of treatment (consisting of the 9 months on treatment, and at month 3 of the off treatment period afterwards).
- Conditions
- Prostate Cancer
- Being tested
- Flutamide, Leuprolide Acetate
- Keywords
- Intermittent Hormone Therapy, Intermittent Androgen Suppression, Biochemical Relapsed Prostate Cancer, Androgen Deprivation Therapy, Localized Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlutamideDrug
Also called Eulexin
Flutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate.
Leuprolide AcetateDrug
Also called Lupron Depot, Eligard, Lupron
Leuprolide Acetate dosed at 7.5mg intramuscular (IM) injections once per month for a total of 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Androgen Suppression (IAS) | Experimental | 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. Receives: Drug: Flutamide; Drug: Leuprolide Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA)
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.
Measured: 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.
Effect of IAS on Overall Survival.
Assessment of overall survival measured as median time from completion of first full cycle of IAS until date of death from any cause.
Measured: From date of first treatment until the date of death or study withdrawal, whichever came first, assessed up to 16 years.
Secondary outcomes (13)
Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS
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.
Measured: From screening prior to first dose of ADT through the start of the second cycle of ADT.
Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS
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.
Measured: From screening prior to first dose of ADT through the start of the second cycle of ADT.
Development of Osteopenia (Bone Loss) During IAS
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.
Measured: From screening prior to first dose of ADT through the start of the second cycle of ADT.
Testosterone Levels During IAS
Testosterone was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.
Measured: Baseline, Month 3, Month 9, and Month 12
Estradiol Levels During First Cycle of IAS
Estradiol was measured at baseline, and at Month 3, Month 9, and Month 12 after the start of the first cycle of ADT.
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Spatial Ability Test (Block Design) During First Cycle of IAS
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).
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS
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.
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Executive Function Testing (Stroop Task) During First Cycle of IAS
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.
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS
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.
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Visual Working Memory Test During First Cycle of IAS
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.
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS
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.
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Spatial Memory Testing During First Cycle of IAS
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.
Measured: Baseline, Month 3, Month 9, and Month 12
Score on Verbal Ability/Fluency Testing During First Cycle of IAS
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.
Measured: Baseline, Month 3, Month 9, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study start8 Jan 1997
- Primary completion6 Sep 2012
- Study completion6 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects underwent androgen suppression with a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate. If PSA reached the appropriate nadir at by month 9, the androgen suppression was interrupted. Once the PSA reached the appropriate threshold, the subjects resumed treatment for another 9 months. These cycle continued until the patient withdrew from the study, was taken off the study due to toxicities or the decision of the investigator, or until the treatment with IAS was no longer effective in controlling the prostate cancer.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Celestia Higano, University of Washington
- Investigators
- Celestia Higano, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223665
- Sponsor's protocol ID
- 30296
- Other IDs
- 973730AC06, HSD 30296
- Acronym
- IAS
- Status last verified
- Aug 2018
- First submitted
- 16 Sep 2005
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuo KF, Hunter-Merrill R, Gulati R, Hall SP, Gambol TE, Higano CS, Yu EY. Relationships between times to testosterone and prostate-specific antigen rises during the first off-treatment interval of intermittent androgen deprivation are prognostic for castration resistance in men with nonmetastatic prostate cancer. Clin Genitourin Cancer. 2015 Feb;13(1):10-6. doi: 10.1016/j.clgc.2014.08.003. Epub 2014 Aug 10.
PubMed 25242417
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Intermittent Androgen Suppression (IAS) in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00223665
- Acronym / sponsor ID
- IAS / 30296
- Conditions
- Prostate Cancer
- Keywords
- Intermittent Hormone Therapy, Intermittent Androgen Suppression, Biochemical Relapsed Prostate Cancer, Androgen Deprivation Therapy, Localized Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 8 Jan 1997 (actual)
- Primary completion
- 6 Sep 2012 (actual)
- Study completion
- 6 Sep 2012 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 14 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard first line treatment for men with early stage newly diagnosed localized prostate cancer is a surgical removal of the prostate, localized external beam radiation, brachytherapy, or a combination of surgery and radiation. In most patients Prostate Specific Antigen (PSA) levels will decline after these localized treatments, demonstrating a response to these therapies. However despite an initial response to localized treatment, some men will go on to later develop a rise in PSA levels, an indicator of Biochemical Relapsed Prostate Cancer (BRPC). For BRPC patients who have not yet developed metastasis, the standard treatment is Androgen Deprivation Therapy (ADT) to decrease levels of Testosterone, subsequently decreasing PSA levels. A low value for the PSA is more desirable as it may indicate no tumor growth.
ADT may be administered as a continuous treatment (Continuous Androgen Suppression, or CAS) or as intermittent treatment (Intermittent Androgen Suppression, or IAS). This treatment is continued until the development of Castration Resistant Prostate Cancer (CRPC), indicated by a rise in PSA despite ADT. Giving the hormone therapy intermittently (in cycles of treatment and off treatment periods) appears to delay the change of prostate cancer to a type of prostate cancer that resists hormone therapy, prolonging efficacy of ADT monotherapy. IAS may also decrease the impact of ADT on mental status.
This study evaluated the effect of intermittent androgen suppression on time to androgen independent progression (the development of castration resistant disease) and overall survival in men with localized prostate cancer. Subjects were also evaluated for the effects of intermittent androgen suppression on a variety of neuro-psychiatric assessments and on bone density.
The subjects in this study had a rising PSA value after definitive therapy either with radical prostatectomy or external beam irradiation for the treatment of prostate cancer. All subjects were males at or over the age of 21 years.
New subjects were introduced to this study protocol (along with other non-study treatment options) during a clinic visit with Dr. Higano or another sub-investigator. After informed consent was obtained, subjects underwent the following screening procedures before starting treatment: Bone density scan (DEXA), Technetium-99 bone scan, CT scan of the chest, abdomen, and pelvis, blood draw, and neuro-psychiatric assessments. Subjects then began androgen suppression with a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate. During the treatment, they had quarterly clinic visits and blood draws. Their PSA levels were monitored monthly, and if their PSA reached the appropriate nadir at by month 9, the androgen suppression was interrupted. At the end of each treatment cycle, subjects underwent another bone density test, blood draw, problem solving test, and neuro-psychiatric assessments.
During the "off treatment" phase, the subject will again had quarterly clinic visits, blood draws, and neuro-psychiatric assessments. PSA and testosterone were be monitored monthly. Once the PSA reached the appropriate threshold, the subject performed another set of screening procedures and resumed treatment for another 9 months. This cycle continued until the patient withdrew from the study, was taken off the study due to toxicities or the decision of the investigator, or until the treatment with IAS was no longer effective in controlling the prostate cancer. The neuro-psychiatric assessments were only performed during the subject's first cycle of treatment (consisting of the 9 months on treatment, and at month 3 of the off treatment period afterwards).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects underwent androgen suppression with a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate. If PSA reached the appropriate nadir at by month 9, the androgen suppression was interrupted. Once the PSA reached the appropriate threshold, the subjects resumed treatment for another 9 months. These cycle continued until the patient withdrew from the study, was taken off the study due to toxicities or the decision of the investigator, or until the treatment with IAS was no longer effective in controlling the prostate cancer.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Androgen Suppression (IAS) | Experimental | Drug: Flutamide, Drug: Leuprolide AcetateIntermittent 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate
- Clinical stage A2, B, C, D1
- Age: older than 21 years old
- Performance status of 0 or 1
- Pretreatment serum testosterone, normal range (or no clinical evidence of testosterone deficiency).
Key exclusion criteria (12 listed)
- Abnormal bone scan suggestive of metastatic osseous disease.
- Previous hormonal manipulation including orchiectomy or any medication with significant antiandrogenic activity (combined androgen suppression over 9 months, monotherapy antiandrogens, estrogens, ketoconazole). *Neoadjuvant androgen suppression therapy of less than or equal to 3 months is allowed, if this androgen suppression therapy was completed more than or equal to 1 year prior to study enrollment AND if the Testosterone level is within the normal ranges.
- Any systemic chemotherapy or curative radiotherapy within 6 months.
- Hepatic dysfunction:
- Renal dysfunction:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlutamideAlso: EulexinFlutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate. | Drug | Intermittent Androgen Suppression (IAS) |
| Leuprolide AcetateAlso: Lupron Depot, Eligard, LupronLeuprolide Acetate dosed at 7.5mg intramuscular (IM) injections once per month for a total of 9 months. | Drug | Intermittent Androgen Suppression (IAS) |
Primary outcome
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.
13 secondary outcomes
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.
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.
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.
Testosterone Levels During IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Estradiol Levels During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Spatial Ability Test (Block Design) During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Executive Function Testing (Stroop Task) During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Visual Working Memory Test During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Spatial Memory Testing During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Score on Verbal Ability/Fluency Testing During First Cycle of IAS
Time frame: Baseline, Month 3, Month 9, and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25242417Kuo KF, Hunter-Merrill R, Gulati R, Hall SP, Gambol TE, Higano CS, Yu EY. Relationships between times to testosterone and prostate-specific antigen rises during the first off-treatment interval of intermittent androgen deprivation are prognostic for castration resistance in men with nonmetastatic prostate cancer. Clin Genitourin Cancer. 2015 Feb;13(1):10-6. doi: 10.1016/j.clgc.2014.08.003. Epub 2014 Aug 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celestia Higano, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flutamide and Leuprolide Acetate in people with Prostate Cancer, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00223665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.