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Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer.

Publication ,  Journal Article
Koontz, BF; Quaranta, BP; Pura, JA; Lee, WR; Vujaskovic, Z; Gerber, L; Haake, M; Anscher, MS; Robertson, CN; Polascik, TJ; Moul, JW
Published in: Int J Radiat Oncol Biol Phys
September 1, 2013

PURPOSE: To evaluate, in a phase 1 study, the safety of neoadjuvant whole-pelvis radiation therapy (RT) administered immediately before radical prostatectomy in men with high-risk prostate cancer. METHODS AND MATERIALS: Twelve men enrolled and completed a phase 1 single-institution trial between 2006 and 2010. Eligibility required a previously untreated diagnosis of localized but high-risk prostate cancer. Median follow-up was 46 months (range, 14-74 months). Radiation therapy was dose-escalated in a 3 × 3 design with dose levels of 39.6, 45, 50.4, and 54 Gy. The pelvic lymph nodes were treated up to 45 Gy with any additional dose given to the prostate and seminal vesicles. Radical prostatectomy was performed 4-8 weeks after RT completion. Primary outcome measure was intraoperative and postoperative day-30 morbidity. Secondary measures included late morbidity and oncologic outcomes. RESULTS: No intraoperative morbidity was seen. Chronic urinary grade 2+ toxicity occurred in 42%; 2 patients (17%) developed a symptomatic urethral stricture requiring dilation. Two-year actuarial biochemical recurrence-free survival was 67% (95% confidence interval 34%-86%). Patients with pT3 or positive surgical margin treated with neoadjuvant RT had a trend for improved biochemical recurrence-free survival compared with a historical cohort with similar adverse factors. CONCLUSIONS: Neoadjuvant RT is feasible with moderate urinary morbidity. However, oncologic outcomes do not seem to be substantially different from those with selective postoperative RT. If this multimodal approach is further evaluated in a phase 2 setting, 54 Gy should be used in combination with neoadjuvant androgen deprivation therapy to improve biochemical outcomes.

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Published In

Int J Radiat Oncol Biol Phys

DOI

EISSN

1879-355X

Publication Date

September 1, 2013

Volume

87

Issue

1

Start / End Page

88 / 93

Location

United States

Related Subject Headings

  • Urinary Incontinence
  • Urethral Stricture
  • Radiotherapy, Conformal
  • Radiotherapy, Adjuvant
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Preoperative Care
  • Pelvis
  • Oncology & Carcinogenesis
 

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Koontz, B. F., Quaranta, B. P., Pura, J. A., Lee, W. R., Vujaskovic, Z., Gerber, L., … Moul, J. W. (2013). Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer. Int J Radiat Oncol Biol Phys, 87(1), 88–93. https://doi.org/10.1016/j.ijrobp.2013.05.014
Koontz, Bridget F., Brian P. Quaranta, John A. Pura, W. R. Lee, Zeljko Vujaskovic, Leah Gerber, Michael Haake, et al. “Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer.Int J Radiat Oncol Biol Phys 87, no. 1 (September 1, 2013): 88–93. https://doi.org/10.1016/j.ijrobp.2013.05.014.
Koontz BF, Quaranta BP, Pura JA, Lee WR, Vujaskovic Z, Gerber L, et al. Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):88–93.
Koontz, Bridget F., et al. “Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer.Int J Radiat Oncol Biol Phys, vol. 87, no. 1, Sept. 2013, pp. 88–93. Pubmed, doi:10.1016/j.ijrobp.2013.05.014.
Koontz BF, Quaranta BP, Pura JA, Lee WR, Vujaskovic Z, Gerber L, Haake M, Anscher MS, Robertson CN, Polascik TJ, Moul JW. Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):88–93.
Journal cover image

Published In

Int J Radiat Oncol Biol Phys

DOI

EISSN

1879-355X

Publication Date

September 1, 2013

Volume

87

Issue

1

Start / End Page

88 / 93

Location

United States

Related Subject Headings

  • Urinary Incontinence
  • Urethral Stricture
  • Radiotherapy, Conformal
  • Radiotherapy, Adjuvant
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Preoperative Care
  • Pelvis
  • Oncology & Carcinogenesis