| Clinical
Trial: |
S9927
– Phase III Prostate Cancer |
| Governing Group: |
Southwest Oncology
Group |
| Title: |
“Intermittent
Androgen Deprivation in Patients with Stage D2 Prostate Cancer, a
Phase II study.” |
Eligibility:
- Patients must have proven adenocarcinoma of the prostate, Stage
D2.
- Patients with possible second primaries allowed only if metastatic
disease histologically confirmed.
- Stage D2 patients meeting the above criteria and who have already
begun the use of combined androgen deprivation therapy are eligible
for a late induction registration to this study if:
- LHRH agonist and antiandrogen therapy was initiated within
the previous six (6) months.
- the effectiveness of the LHRH against depot would not extend
beyond eight (8) months since the initiation of CAD and
- PSA values and all other requirements per the Study Calendar
for month 6 are or will be available.
- Patients on LHRH agonist only (monotherapy) are eligible for
late induction registration provided that they were treated initially
with LHRH agonist plus antiandrogen to prevent flare and meet
the following criteria:
- First dose of LHRH agonist must be within six (6) months
prior to registration.
- the effectiveness of the current depot LHRH agonist would
not extend beyond eight (8) months since initiation of treatment
with CAD.
- PSA values from and all other requirements per the Study
Calendar for month six (6) are or will be available.
- Patients must be placed on CAD when registered.
- PSA greater than or equal to 5 ng/ml, prior neoadjuvant or
adjuvant HT allowed, only if received within four (4) months.
- Prior finasteride allowed if given for BPH within (nine) 9
months.
- Both neoadjuvant or adjuvant HT or finasteride must be discontinued
one year prior to registration.
- No concomitant chemotherapy, BRM, HT or radiation
- Patients with acute cord compression are not eligible.
- Adequate renal and hepatic function.
- Patients must meet PSA normal criteria for randomization at
month eight (8).
- Randomization will occur only if both the month six (6) and
month seven (7) PSA results are stable or declining (PSA less
than or equal to 4.0/ng/ml on previous two months).
|
