21 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA)Primary· 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.
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
4.0
0.5 – 8.6
Effect of IAS on Overall Survival.Primary· 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.
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
6.6
2.9 – 13.0
Change in Standardized Bone Mineral Density (BMD) of the Spine During IASSecondary· 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.
Post Cycle 1 versus Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
-3.4
Pre Cycle 2 versus Post Cycle 1
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
1.4
Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IASSecondary· 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.
Post Cycle 1 versus Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
-1.2
Pre Cycle 2 versus Post Cycle 1
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
-0.2
Development of Osteopenia (Bone Loss) During IASSecondary· 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.
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
13.2
Testosterone Levels During IASSecondary· 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.
Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
406
± 1.6
Measurement at Month 3
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
0.28
± 0.24
Measurement at Month 9
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
0.20
± 0.07
Measurement at Month 12
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
2.45
± 1.35
Estradiol Levels During First Cycle of IASSecondary· 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.
Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
33.60
± 17.29
Measurement at Month 3
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
23.12
± 6.56
Measurement at Month 9
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
22.76
± 5.75
Measurement at Month 12
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
24.35
± 6.46
Score on Spatial Ability Test (Block Design) During First Cycle of IASSecondary· 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).
Baseline
Group
Value
95% CI
Combined Androgen Blockade
8.65
± 0.81
Score at Month 3
Group
Value
95% CI
Combined Androgen Blockade
7.20
± 1.21
Score at Month 9
Group
Value
95% CI
Combined Androgen Blockade
8.82
± 0.53
Score at Month 12
Group
Value
95% CI
Combined Androgen Blockade
8.47
± 1.06
Score on Spatial Ability Test (Mental Rotation) During First Cycle of IASSecondary· 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.
Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
16.12
± 3.39
Score at Month 3
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
13.00
± 3.01
Score at Month 9
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
16.52
± 2.42
Score at Month 12
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
15.53
± 3.08
Score on Executive Function Testing (Stroop Task) During First Cycle of IASSecondary· 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.
Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
51.00
± 18.15
Score at Month 3
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
55.52
± 22.11
Score at Month 9
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
47.58
± 11.64
Score at Month 12
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
48.82
± 13.31
Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IASSecondary· 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.
Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
21.31
± 5.50
Score at Month 3
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
22.90
± 5.03
Score at Month 9
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
22.70
± 5.33
Score at Month 12
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
22.70
± 4.33
Score on Visual Working Memory Test During First Cycle of IASSecondary· 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.
Baseline
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
13.22
± 9.70
Score at Month 3
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
15.66
± 8.50
Score at Month 9
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
12.35
± 10.16
Score at Month 12
Group
Value
95% CI
Intermittent Androgen Suppression (IAS)
14.00
± 11.04
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected for each patient from the start of treatment until discontinuation from the study, an average of 16 years per patient..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04597099 — Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion
· EARLY_PHASE1
· unknown
NCT05050084 — Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients
· Phase 3
· active not recruiting
NCT04513717 — Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk
· Phase 3
· active not recruiting
NCT04248621 — Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients
· Phase 4
· unknown
NCT03507608 — Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
· EARLY_PHASE1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 7 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00223665.