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The aim of the study is
The incidence rate of prostate cancer is rapidly increasing, and it has become the most prevalent solid tumor diagnosed in men.
In most cases the prostate cancer is organ-confined at the time of initial diagnosis . Radical prostatectomy and radiotherapy, either given as a seed implant or external beam radiation therapy, are the accepted standard options for treating the primary tumor itself, and androgen deprivation may be added selectively for certain cases with an intermediate or high risk of dissemination based on clinical and pathologic features evident at the time of diagnosis.
Regarding the specific option of external beam radiotherapy, the current widely accepted standard regimen for organ-confined prostate cancer involves approximately eight weeks of fractionated treatments with a daily dose of 1.8-2.0 Gy to a total dose in the range of 70-80 Gy .
Over the last decade, there have been three major advances in the use of external RT for the management of clinically localized prostate cancer: (a) androgen deprivation therapy ; (b) image-guided ration therapy with three-dimensional conformal radiotherapy and intensity modulated radiotherapy , and particularly c) radiation dose escalation schedules compared with conventional 70-80 Gy (2 Gy per fraction), which has been shown to improve biochemical and distant metastases control with minimum toxicity, but not overall survival .
The rapid dose gradients, which are able to be generated with Intensity Modulated Radiation Therapy have been demonstrated to reduce OAR dose relative to three-dimensional conformal radiotherapy resulting in well-established reductions in toxicity in the conventionally fractionated, dose escalated prostate cancer radiotherapy setting .
The use of conventional fractionated radiation therapy with a single 1.8-2 Gy fraction/day is related to more radiation therapy sessions and longer treatments; therefore, influencing the decision-making and patient non-adherence, since longer treatments can affect their financial situation (by not being able to work during radiotherapy) or cause a disruption in their daily life .
Hypofractionated Radiation Therapy and conventional fractionated radiation therapy schedules have been shown to be isoeffective in terms of incidence of biochemical control or late complications in several phase III trials .
The aim of the study is
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | hypofractionated Intensity-Modulated Radiation Therapy |
|
| Group B | Active Comparator | conventional fractionated Intensity-Modulated Radiation Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Intensity-Modulated Radiation Therapy | Radiation | Moderately hypofractionated schedule include 60 Gy in 20fx (3 Gy/fx) over 4 weeks (5 fractions/week). The prostate will be prescribed 60 Gy in 20 fx (3 Gy/fx). Proximal seminal vesicles will be prescribed 48-50 Gy in 2.4-2.5 Gy/fx, Entire seminal vesicles will be prescribed full dose (60 Gy) in case of evidence of seminal vesicle invasion on multi parametric MRI. If treating the elective pelvic LNs (risk of involvement >20% according to roach formula), prescribed dose will be 44 Gy in 2.2 Gy/fx. A simultaneous integrated boost technique will be utilized with moderate hypo fractionation). |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Evaluation of tumor response will be performed by digital rectal examination, prostate-specific antigen, testosterone levels and Magnetic resonance imaging abdomen & pelvis with contrast 3-monthly the first year after radiation therapy, 4-monthly the second and third year. | Three monthly the first year after radiation, 4 months the second and third year. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nada El-Behiri | Assistant lecturer of Clinical Oncology& Nuclear Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Egypt |
Data will be available if it needed
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| Conventional Intensity-Modulated Radiation Therapy | Radiation | Conventional fractionation of 76 Gy in 38 fractions (5 fractions/week) at 2.0 Gy/fraction over 8 weeks. The prostate will be prescribed 76 Gy in 38 fractions (2 Gy/fx). Proximal seminal vesicles will be prescribed 54-66Gy (2Gy/fx), paying attention to bowel toxicity. Entire seminal vesicle will be prescribed full dose (76 Gy) in case of evident seminal vesicle invasion on MRI. If treating elective pelvic lymph nodes (risk of involvement >20% according to roach formula), prescribed dose will be 45-50 Gy. |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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