For localized prostate cancer, radiotherapy (RT) is an accepted option for primary (definitive) treatment. Other options include surgery (radical prostatectomy), hormonal treatment, or active surveillance.
In the postoperative setting, RT to the prostate bed is an accepted procedure for individuals with an increased risk of local recurrence, based on three (3) randomized controlled trials that showed a significant increase in biochemical recurrence-free survival. Professional society guidelines have recommended adjuvant RT to individuals with adverse pathologic findings at the time of prostatectomy and salvage RT for individuals with prostate-specific antigen recurrence or local recurrence after prostatectomy in the absence of metastatic disease.
Radiation therapy may be administered externally (i.e., a beam of radiation is directed into the body) or internally (i.e., a radioactive source is placed inside the body, near a tumor). External radiotherapy (RT) techniques include "conventional" or two (2)-dimensional (2D) RT, three (3)-dimensional (3D) conformal RT, and intensity-modulated radiation therapy (IMRT).
Conventional External-Beam Radiotherapy
Methods to plan and deliver RT have evolved that permit more precise targeting of tumors with complex geometries. Conventional 2D treatment planning utilizes X-ray films to guide and position radiation beams. Bony landmarks bones visualized on X-ray are used to locate a tumor and direct the radiation beams. The radiation is typically of uniform intensity.
Three-Dimensional Conformal Radiotherapy
Radiation treatment planning has evolved to use 3D images, usually from computed tomography (CT) scans, to more precisely delineate the boundaries of the tumor and to discriminate tumor tissue from adjacent normal tissue and nearby organs at risk for radiation damage. Three-dimensional conformal RT (3D-CRT) involves initially scanning the individual in the position that will be used for the radiation treatment. The tumor target and surrounding normal organs are then outlined in 3D on the scan. Computer software assists in determining the orientation of radiation beams and the amount of radiation the tumor and normal tissues receive to ensure coverage of the entire tumor in order to minimize radiation exposure for at risk normal tissue and nearby organs. Other imaging techniques and devices such as multi-leaf collimators (MLCs) may be used to "shape" the radiation beams. Methods have also been developed to position the individual and the radiation portal reproducibly for each fraction and to immobilize the individual, thus maintaining consistent beam axes across treatment sessions.
IMRT is the more recent development in external radiation. Treatment planning and delivery are more complex, time-consuming, and labor-intensive for IMRT than for 3D-CRT. Similar to 3D-CRT, the tumor and surrounding normal organs are outlined in 3D by a scan and multiple radiation beams are positioned around the individual for radiation delivery. In IMRT, radiation beams are divided into a grid-like pattern, separating a single beam into many smaller "beamlets". Specialized computer software allows for "inverse" treatment planning. The radiation oncologist delineates the target on each slice of a CT scan and specifies the target's prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally reconstructed radiographic image of the tumor, surrounding tissues, and organs at risk, computer software optimizes the location, shape, and intensities of the beam ports to achieve the treatment plan's goals.
Summary of Evidence
For individuals who have localized prostate cancer and are undergoing definitive RT who received IMRT, the evidence includes several prospective comparative studies, retrospective studies, and systematic reviews. Relevant outcomes are overall survival (OS), disease-free survival (DFS), disease specific survival, quality of life, and treatment-related morbidity. Although there are few prospective comparative trials, the evidence has generally shown that IMRT provides survival outcomes similar to 3-dimensional conformal radiotherapy (3D-CRT) while reducing gastrointestinal (GI) and genitourinary (GU) toxicity. These findings are supported by treatment planning studies, which have predicted that IMRT improves target volume coverage and sparing of adjacent organs compared with 3D-CRT. A reduction in clinically significant complications of RT is likely to improve the quality of life for treated patients. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have prostate cancer and are undergoing RT after prostatectomy who receive IMRT, the evidence includes retrospective comparative studies, single-arm phase two (2) trials, and systematic reviews. Relevant outcomes are OS, DFS, disease specific survival, quality of life, and treatment-related morbidity. Although the comparative studies are primarily retrospective, the evidence has generally shown that IMRT compared favorably to 3D-CRT with regard to GI and GU toxicity. Notably, a retrospective comparative study found a significant reduction in acute upper GI toxicity with IMRT compared with 3D-CRT, mainly due to better bowel sparing with IMRT. Another retrospective comparative study found a reduction in GU toxicity. A reduction in clinically significant complications of RT is likely to improve the quality of life for treated individuals. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.