OBJECTIVES:
Primary
- To determine whether the addition of short-term androgen deprivation (STAD) to
prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e.,
maintenance of a prostate-specific antigen [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 radiotherapy after radical
prostatectomy.
- To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves
FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy
after radical prostatectomy.
Secondary
- To compare secondary biochemical failure, the development of hormone-refractory
disease , distant metastasis, cause-specific mortality, and overall mortality at
five years.
- To compare acute and late morbidity based on Common Toxicity Criteria for Adverse
Effects (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.
- To assess whether mood is improved and depression is decreased with the more
aggressive therapy if it improves FFP.
- To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat
cells for future translational research analyses.
Tertiary
- To assess whether an incremental gain in FFP and survival with more aggressive
therapy outweighs decrements in the primary generic domains of HRQOL (i.e.,
mobility, self care, usual activities, pain/discomfort, and anxiety/depression).
- 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.
- To assess associations between serum levels of beta-amyloid and measures of
cognition and mood and depression.
- 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.
OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no),
prostatectomy Gleason score (≤ 7 vs 8-9), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs
> 1.0 and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others).
Patients are randomized to 1 of 3 treatment arms.
Follow-up occurs 3, 6, and 12 months after the completion of radiation therapy, then
every 6 months for 6 years, and then annually thereafter.