Yea I understood his point but that does not address my point. But it's irrelevant to Sonny's post and I'll raise my hypothesis at PCAF for future discussion.
As far as the S1216 protocol definitions. The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
From the protocol capsule:
1.1 Primary Objective
The primary objective of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
1.2 Secondary Objectives
Secondary objectives include the following:
a. To compare progression free survival (as defined in Section 10.5) between the two arms.
b. To compare distributions of PSA response (< 0.2 vs. 0.2-4.0 vs. > 4.0 ng/ml) between the treatment arms at 7 months post-randomization.
c. To compare the qualitative and quantitative adverse events from each treatment arm.
d. To characterize the long-term survival in both treatment arms after 10 years of follow-up.
1.3 Other Objectives
Other objectives include the following:
a. To validate the prognostic and predictive value of markers of bone turnover in newly-diagnosed metastatic hormone sensitive prostate cancer patients treated with TAK-700.
b. To bank serum/whole blood and tissue specimens for future use.
Sonny is eligible to stay on protocol and/or:
7.2 Concomitant Therapy
The use of supportive care medications is allowed according to institutional standards.
Several medications are specifically disallowed. Five-alpha reductase inhibitor (e.g. finasteride and dutasteride) are not permitted. Other excluded therapies include ketoconazole, aminoglutethimide, abiraterone acetate, enzalutamide (MDV3100), diethylstilbestrol/DES, and other estrogen preparations.
7.4 Criteria for Removal from Protocol Treatment:
a. Progression of disease or symptomatic deterioration (as defined in Section 10.3).
b. Unacceptable toxicity due to LHRH agonist. NOTE: Patients off bicalutamide or TAK 700, but continuing on LHRH agonist remain on protocol treatment.
c. Delay in LHRH agonist greater than 60 days.
d. Beginning a new systemic treatment for prostate cancer.
e. The patient may withdraw from the study at any time for any reason.
We did a modification that was approved to allow docetaxel + prednisone.