Efficacy of Irradiation (RT) and External Hyperthermia (HT) in Patients with Clinically Symptomatic, Locally Advanced, Hormone Refractory +/??? Radiation Recurrent Prostate Cancer Preliminary Report of Phase I/II Study: P-30

Purpose: There are few reports of RT and HT in locally advanced, hormone refractory (LAHRPC) +/- RT recurrent prostate cancer. A preliminary report of a phase I/II study is presented. Materials and Methods: Between 1997 and 2001, 7 patients with RT- recurrent LAHRPC had reirradiation (reRT) 36–50 Gy at 1.8 Gy/fr. and HT(GpA). Two patients with LAHRPC and no prior RT, had external RT-66 Gy and HT (GpB). In GpA the mean initial RT dose was 66 Gy with a 9 yr. median interval to reRT. All had very large tumors with symptoms such as pelvic pain, hematuria, rectal/bladder invasion or lymphedema. HT was delivered during RT twice weekly for 8–10 treatments with BSD 2000-sigma 60 applicator. In four patients with LAHRPC and without metastases, the PSA half life (Th) was calculated from PSA vs Time plots of the form logPSA=logA + BT. Results: Median follow up is 16 m. (2m-36m). All patients had resolution of symptoms by end of RT-HT. All patients had complete response (CR) by serial imaging/endoscopy, 2–6 months after RT-HT. At last follow-up 6/8 patients had local tumor control. One recurred in rectum at 17 m. and another in bladder at 8 m. One is just 2 m. after RT-HT. Two had Grade 1 rectal bleeding, and none had incontinence or fistulae. A significant decline in PSA was observed among four patients without metastases. Two GpA patients with pretreatment PSA of 12ng/ml and 31ng/ml achieved >0.1 PSA at 4 and 7 months after reRT-HT, and PSA Th was 23 and 80 days respectively. In two GpB patients the pretreatment PSA(day 0) was 318 and 694; day 20 PSA (during RT-HT) was 143 and 551; day 50 PSA was 2.0 and 303; and by day 80 it was > 0.1 and 190; the first patient has PSA of >0.1 at 18m. and the other is only 2 m. post treatment. The PSA Thwas 7 days and 60 days in these two patients. Conclusion: This report demonstrates that RT-HT results in rapid PSA decline, significant tumor regression with durable symptom palliation for 1–3 years, with minimal complications thus far.