Acute gastrointestinal, genitourinary, and dermatological toxicity during dose-escalated 3D-conformal radiation therapy (3DCRT) using an intrarectal balloon for prostate gland localization and immobilization.

PURPOSE: We determined the acute gastrointestinal (GI), genitourinary (GU), and dermatologic (D) toxicity during dose-escalated three-dimensional conformal radiation therapy (3DCRT). A modified intrarectal balloon (Medrad) was used for prostate gland localization and immobilization. METHODS: Forty-six men with clinical category T1c to T3a, and at least one high-risk feature (PSA >10, Gleason > or =7, or MRI evidence of extracapsular extension or seminal vesical invasion) comprised the study cohort. Treatment consisted of hormonal therapy and 4-field 3DCRT using an intrarectal balloon for the initial 15 of 40 treatments. Planning treatment volume dose was 72 Gy (95% normalization). A Mantel-Haenzel Chi-square test compared the distribution of GU, GI, and D symptoms at baseline and at end of treatment (EOT). RESULTS: There was no significant difference between the 2 time points in the proportion of patients with bowel symptoms (p = 0.73), tenesmus (p = 0.27), nocturia (p = 1.00), or GU urgency (p = 0.40). However, there was a significant decrease in GU frequency (70% vs. 50%, p = 0.46) as a result of medical interventions and a significant increase in hemorrhoidal irritation (4% vs. 20%, p = 0.02) and anal cutaneous skin reaction (0% vs. 70%, p < 0.001). By 3 months after EOT compared to baseline, there was no significant difference in the proportion of patients experiencing hemorrhoidal bleeding (4% vs. 8%, p = 0.52), requiring intervention for hemorrhoidal symptoms (7% vs. 5%, p = 0.8), or experiencing persistent anal cutaneous skin reaction (0% vs. 3%, p = 0.31). CONCLUSION: Dose-escalated 3DCRT using an intrarectal balloon for prostate localization and immobilization was well tolerated. Acute GU, GI, and D symptoms resolved with standard dietary or medical interventions by the EOT or shortly thereafter.

Using the magnitude of PSA bounce after MRI-guided prostate brachytherapy to distinguish recurrence, benign precipitating factors, and idiopathic bounce.

PURPOSE: To identify events that precipitated a prostate-specific antigen (PSA) bounce and characterize the magnitude, duration, and time to PSA bounce after MRI-guided prostate brachytherapy. METHODS AND MATERIALS: Between 1997 and 2001, 186 patients with low-risk prostate cancer underwent MRI-guided permanent 125I source implantation, with or without external beam radiotherapy. A PSA bounce was defined as a >or=15% elevation in PSA compared with the most recent value, followed by a decline to a level at or less than the prebounce value. At the time of PSA measurement, data were prospectively collected on whether the patient had recent ejaculation, ongoing radiation proctitis, or recent instrumentation. RESULTS: A total of 115 patients (61.8%) had a total of 156 PSA bounces. Of these, 36 patients had PSA bounces associated with ejaculation, proctitis, or instrumentation, and 79 experienced idiopathic PSA bounces (not associated with a precipitating event). The magnitude of the PSA bounce was significantly lower for the idiopathic PSA bounce (0.6 ng/mL) compared with that associated with ejaculation (p = 0.003), proctitis (p <0.0001), or instrumentation (p = 0.007). Patients with biopsy-proven local recurrence had a median PSA elevation of 1.2 ng/mL, significantly higher (p = 0.006) than the magnitude of the idiopathic PSA bounce, but not significantly different from the magnitude of the PSA bounce due to ejaculation, proctitis, or instrumentation. CONCLUSION: In patients treated with MRI-guided prostate brachytherapy, recent ejaculation, instrumentation, or ongoing radiation proctitis can cause a transient increase in PSA, the magnitude of which is significantly higher than that for idiopathic PSA bounce, but is similar to that in patients with recurrent disease.

A prospective evaluation of rectal bleeding after dose-escalated three-dimensional conformal radiation therapy using an intrarectal balloon for prostate gland localization and immobilization.

OBJECTIVES: To estimate the rates of rectal bleeding after dose-escalated three-dimensional conformal radiation therapy (3D-CRT) on a prospective, Phase II study in which a modified intrarectal balloon was used for prostate gland localization and immobilization. METHODS: The study cohort comprised 100 men with biopsy-proven adenocarcinoma of the prostate and at least one high-risk feature (prostate-specific antigen level greater than 10 ng/mL, Gleason score 7 or higher, or clinical or radiographic T3 disease). Treatment consisted of androgen suppression therapy and four-field 3D-CRT with an intrarectal balloon for the initial 15 treatments. Planning treatment volume dose was 75.6 Gy. The primary endpoint of time to grade 3 rectal bleeding was estimated with the Kaplan-Meier method for 57 men with a minimum follow-up of 1 year. RESULTS: For 57 men with a median (range) follow-up of 1.8 (1.0 to 3.3) years, the median (range) volume of rectum exceeding 70 Gy was 3.7 (0.6 to 14.7) cm3, and the 2-year estimate of grade 3 rectal bleeding rate was 10%. This rate was 100% as compared with 0 (P < 0.0001) for men who were taking warfarin (n = 3) or high-dose aspirin (n = 1) as compared with neither, respectively. All grade 3 rectal bleeding events were controlled with argon plasma coagulation. CONCLUSIONS: Dose-escalated 3D-CRT with an intrarectal balloon technique for prostate localization and immobilization produced no measurable grade 3 rectal bleeding unless the patient was taking anticoagulants.

Late genitourinary and gastrointestinal toxicity after magnetic resonance image-guided prostate brachytherapy with or without neoadjuvant external beam radiation therapy.

BACKGROUND: This study was designed to estimate the rates of late genitourinary (GU) and rectal toxicity after magnetic resonance image (MRI)-guided prostate brachytherapy exclusively or in conjunction with external beam radiation therapy (EBRT). METHODS: Between November 1997 and April 2002, 201 patients with category T1C prostate carcinoma (according to the 2002 American Joint Committee on Cancer staging criteria), prostate specific antigen levels < 10 ng/mL, and biopsy Gleason score 3 + 4 disease were treated with MRI-guided brachytherapy exclusively or in conjunction with EBRT. The MRI-guided technique was designed to spare the urethra based on delivery of the prescription dose to the peripheral zone exclusively. The Kaplan-Meier method was used to estimate rates of freedom from late GU and rectal toxicity. Comparisons were made using a log-rank test. RESULTS: At a median follow-up of 2.8 years (range, 0.5-5.0 years), the 4-year estimates of rectal bleeding requiring coagulation for patients who underwent implantation therapy, compared with patients who received combined-modality therapy, were 8% versus 30%, respectively (log-rank P value = 0.0001). Although erectile dysfunction was common (range, 82-93%), with the use of sildenafil citrate (Viagra), it was estimated that at least two-thirds of patients had erectile function comparable to or superior to baseline function, independent of whether they received monotherapy or combined-modality therapy (P = 0.46). The 4-year estimate of freedom from radiation cystitis was 100% versus 95% (P = 0.01) for patients who received monotherapy and patients who received combined-modality therapy, respectively. No urethral strictures were observed, and no patients underwent postimplantation transurethral resection of the prostate. CONCLUSIONS: In the current study, rectal bleeding after MRI-guided prostate brachymonotherapy was infrequent, and urethral and bladder toxicity is reported to be rare and may be attributed to the urethral-sparing technique of the MRI-guided approach.