Phase II Trial of Radiation Dose Escalation With Conformal External Beam Radiotherapy and High-Dose-Rate Brachytherapy Combined With Long-Term Androgen Suppression in Unfavorable Prostate Cancer: Feasibility Report

Valero, Jeanette; Cambeiro, Mauricio; Galán, Carlos; Teijeira, Mercedes; Romero, Pilar; Zudaire, Javier; Moreno, Marta; Ciérvide, Raquel; Aristu, José Javier; Martínez-Monge, Rafael

doi:10.1016/j.ijrobp.2009.01.059

« Previous Next »International Journal of Radiation Oncology * Biology * Physics
Volume 76, Issue 2 , Pages 386-392, 1 February 2010

Phase II Trial of Radiation Dose Escalation With Conformal External Beam Radiotherapy and High-Dose-Rate Brachytherapy Combined With Long-Term Androgen Suppression in Unfavorable Prostate Cancer: Feasibility Report

Jeanette Valero, M.D.
- Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Navarre, Spain
Mauricio Cambeiro, M.D.
- Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Navarre, Spain
Carlos Galán, M.D.
- Department of Radiation Oncology, Hospital de la Rioja, Logroño, Spain
Mercedes Teijeira, M.D.
- Department of Radiation Oncology, Hospital Divino Vallés, Burgos, Spain
Pilar Romero, M.D.
- Department of Radiation Oncology, Hospital de Navarra, Pamplona, Spain
Javier Zudaire, M.D.
- Department of Urology, Clínica Universitaria de Navarra, University of Navarre, Navarre, Spain
Marta Moreno, M.D.
- Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Navarre, Spain
Raquel Ciérvide, M.D.
- Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Navarre, Spain
José Javier Aristu, M.D.
- Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Navarre, Spain
Rafael Martínez-Monge, M.D.
- Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Navarre, Spain
- Reprint requests to: Rafael Martínez-Monge, M.D., Department of Oncology, Clínica Universitaria de Navarra, University of Navarre, Avda Pío XII s/n, 31080 Pamplona, Navarre, Spain. Tel: (+34) 948-255400; Fax: (+34) 948-255500

Received 18 November 2008; received in revised form 26 January 2009; accepted 29 January 2009. published online 11 May 2009.

Purpose

To determine the feasibility of combined long-term luteinizing hormone-releasing hormone agonist–based androgen suppressive therapy (AST) and dose escalation with high-dose-rate (HDR) brachytherapy for high-risk (HRPC) or very-high-risk prostate cancer (VHRPC).

Methods and Materials

Between January 2001 and October 2006, 134 patients (median age, 70 years) with either National Comprehensive Cancer Network criteria–defined HRPC (n = 47, 35.1%) or VHRPC (n = 87, 64.9%) were prospectively enrolled in this Phase II trial. Tumor characteristics included a median pretreatment prostate-specific antigen level of 14.6 ng/mL, a median clinical stage of T2c, and a median Gleason score of 7. Three-dimensional conformal radiotherapy (54 Gy in 30 fractions) was followed by HDR brachytherapy (19 Gy in 4 b.i.d. treatments). Androgen suppressive therapy started 0–3 months before three-dimensional conformal radiotherapy and continued for 2 years.

Results

One implant was repositioned with a new procedure (0.7%). Five patients (3.7%) discontinued AST at a median of 13 months (range, 6–18 months) because of disease progression (n = 1), hot flashes (n = 2), fatigue (n = 1), and impotence (n = 1). After a median follow-up of 37.4 months (range, 24–90 months), the highest Radiation Therapy Oncology Group–defined late urinary toxicities were Grade 0 in 47.8%, Grade 1 in 38.1%, Grade 2 in 7.5%, and Grade 3 in 6.7% of patients. Maximal late gastrointestinal toxicities were Grade 0 in 73.1%, Grade 1 in 16.4%, Grade 2 in 7.5%, and Grade 3 in 2.9% of patients. There were no Grade 4 or 5 events.

Conclusions

Intermediate-term results show that dose escalation with HDR brachytherapy combined with long-term AST is feasible and has a toxicity profile similar to that reported by previous HDR brachytherapy studies.

Prostate cancer, High and very high risk, Androgen suppressive therapy, 3D-CRT, HDR brachytherapy