Phase 2
Completed N=102
Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer
Source: ClinicalTrials.gov NCT00223665 ↗Enrolled (actual)
102
Serious AEs
4.9%
Results posted
May 2018
Primary outcomePrimary: Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA) — 4.0 years
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA) |
4.0 | — |
| PRIMARY Effect of IAS on Overall Survival. |
6.6 | — |
| SECONDARY Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS |
-3.4; 1.4 | — |
| SECONDARY Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS |
-1.2; -0.2 | — |
| SECONDARY Development of Osteopenia (Bone Loss) During IAS |
13.2 | — |
| SECONDARY Testosterone Levels During IAS |
406; 0.28; 0.20; 2.45 | — |
| SECONDARY Estradiol Levels During First Cycle of IAS |
33.60; 23.12; 22.76; 24.35 | — |
| SECONDARY Score on Spatial Ability Test (Block Design) During First Cycle of IAS |
8.65; 7.20; 8.82; 8.47 | — |
| SECONDARY Score on Spatial Ability Test (Mental Rotation) During First Cycle of IAS |
16.12; 13.00; 16.52; 15.53 | — |
| SECONDARY Score on Executive Function Testing (Stroop Task) During First Cycle of IAS |
51.00; 55.52; 47.58; 48.82 | — |
| SECONDARY Score on Verbal Memory Testing (Proactive Interference) During First Cycle of IAS |
21.31; 22.90; 22.70; 22.70 | — |
| SECONDARY Score on Visual Working Memory Test During First Cycle of IAS |
13.22; 15.66; 12.35; 14.00 | — |
| SECONDARY Score on Verbal Memory Testing (Story Recall) During First Cycle of IAS |
35.06; 37.86; 39.38; 41.16 | — |
| SECONDARY Score on Spatial Memory Testing During First Cycle of IAS |
19.50; 22.00; 23.76; 24.12 | — |
| SECONDARY Score on Verbal Ability/Fluency Testing During First Cycle of IAS |
24.65; 26.15; 26.29; 25.70 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT00223665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.