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A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

Primary To determine whether the addition of NC-STAD to PBRT improves freedom from progression (FFP) [maintenance of a PSA less than the nadir+2 ng/mL, absence of clinical failure and absence of death from any cause] for 5 years, over that of PBRT alone in men treated with salvage RT after radical prostatectomy; To determine whether NC-STAD+PLNRT+PBRT improves FFP over that of NC-STAD+PBRT and PBRT alone in men treated with salvage RT after radical prostatectomy. Secondary To compare the rates of a PSA greater than or equal to 0.4 ng/mL and rising at 5 years after randomization (secondary biochemical failure endpoint), the development of hormone refractory disease (3 rises in PSA during treatment with salvage androgen deprivation therapy), distant metastasis, cause-specific mortality and overall mortality; To compare acute and late morbidity based on CTCAE, v. 3.0; To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related genes in archival diagnostic tissue to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used; To quantify blood product based proteomic and genomic (single nucleotide polymorphisms) patterns, and urine-based genomic patterns before and at different times after treatment to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used; To assess the degree, duration, and significant differences of disease-specific health related quality of life (HRQOL) decrements among treatment arms; it is hypothesized that QOL as measured by the EPIC will significantly worsen by the increasing aggressiveness of treatment and that cognition as measured by the neurocognitive test battery (the HVLT-R, Trail Making Test, parts A & B, and the COWAT) will be significantly worse in the arms with NC-STAD. To assess whether mood is improved and depression is decreased with the more aggressive therapy if it improves FFP; it is hypothesized that QOL as measured by the HSCL-25 will significantly improve with the increasing aggressiveness of treatment due to improved FFP. An exploratory aim is to assess whether an incremental gain in FFP and survival with more aggressive therapy outweighs decrements in the primary generic domains of health related quality of life (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression). This aim is reported as the Quality Adjusted FFP Year (QAFFPY) and as the Quality Adjusted Life Year (QALY). The QAFFPY and QALY will be compared among treatment arms and to the literature as described in Section 1.6. An exploratory aim is to evaluate the cost-utility of the treatment arm demonstrating the most significant benefit (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies. Cost-utility will be assessed by the EQ-5D among treatment arms to determine which therapy dominates. An exploratory aim is to assess associations between serum levels of beta-amyloid (Abeta) and measures of cognition (as measured by the HVLT-R, Trail Making Tests, parts A & B, or the COWAT) and mood and depression (as measured by the HSCL-25). To collect paraffin-embedded tissue blocks, serum, plasma, urine, and whole blood for future translational research analyses An exploratory aim is to assess the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading system.

Primary To determine whether the addition of NC-STAD to PBRT improves freedom from progression (FFP) [maintenance of a PSA less than the nadir+2 ng/mL, absence of clinical failure and absence of death from any cause] for 5 years, over that of PBRT alone in men treated with salvage RT after radical prostatectomy; To determine whether NC-STAD+PLNRT+PBRT improves FFP over that of NC-STAD+PBRT and PBRT alone in men treated with salvage RT after radical prostatectomy. Secondary To compare the rates of a PSA greater than or equal to 0.4 ng/mL and rising at 5 years after randomization (secondary biochemical failure endpoint), the development of hormone refractory disease (3 rises in PSA during treatment with salvage androgen deprivation therapy), distant metastasis, cause-specific mortality and overall mortality; To compare acute and late morbidity based on CTCAE, v. 3.0; To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related genes in archival diagnostic tissue to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used; To quantify blood product based proteomic and genomic (single nucleotide polymorphisms) patterns, and urine-based genomic patterns before and at different times after treatment to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used; To assess the degree, duration, and significant differences of disease-specific health related quality of life (HRQOL) decrements among treatment arms; it is hypothesized that QOL as measured by the EPIC will significantly worsen by the increasing aggressiveness of treatment and that cognition as measured by the neurocognitive test battery (the HVLT-R, Trail Making Test, parts A & B, and the COWAT) will be significantly worse in the arms with NC-STAD. To assess whether mood is improved and depression is decreased with the more aggressive therapy if it improves FFP; it is hypothesized that QOL as measured by the HSCL-25 will significantly improve with the increasing aggressiveness of treatment due to improved FFP. An exploratory aim is to assess whether an incremental gain in FFP and survival with more aggressive therapy outweighs decrements in the primary generic domains of health related quality of life (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression). This aim is reported as the Quality Adjusted FFP Year (QAFFPY) and as the Quality Adjusted Life Year (QALY). The QAFFPY and QALY will be compared among treatment arms and to the literature as described in Section 1.6. An exploratory aim is to evaluate the cost-utility of the treatment arm demonstrating the most significant benefit (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies. Cost-utility will be assessed by the EQ-5D among treatment arms to determine which therapy dominates. An exploratory aim is to assess associations between serum levels of beta-amyloid (Abeta) and measures of cognition (as measured by the HVLT-R, Trail Making Tests, parts A & B, or the COWAT) and mood and depression (as measured by the HSCL-25). To collect paraffin-embedded tissue blocks, serum, plasma, urine, and whole blood for future translational research analyses An exploratory aim is to assess the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading system.