Protocol Title:

A Phase III Trial of the Use of Long Term Androgen Suppression Following Neoadjuvant Hormonal Cytoreduction and Radiotherapy in Locally Advanced Carcinoma of the Prostate

Protocol Status:

Closed

Protocol Number:

R 9202

Type of Cancer:

Prostate Cancer

Principal Investigator:

Ted Deweese, M.D.

Phase Number:

III

Summary:

The study closed to accrual April 15, 1995 with 1554 cases accessioned nationally. Twenty cases were accessioned by Johns Hopkins. Ten patients were randomized to ARM I (Zoladex + Flutamide 2 months before and during RT. Ten patients were randomized to Arm II(Zoladex + Flutamide two months before and during RT, then Zoladex alone for a least 2 years).

As stated in the abstract that was presented at the 2000 ASTRO meeting RTOG 9202 shows a significant improvement in local progression, disease-free survival, freedom from distant metastasis, and biochemical control for RT and Long Term Androgen Deprivation (LTAD) compared to Radiation and Short Term Androgen Deprivation (STAD). Grade 3 and 4 GI morbidity is increased with Long Term Androgen Deprivation and Radiation.