Prostate Cancer
Conditions
Keywords
Prostatic Neoplasms, radiotherapy
Brief summary
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
Interventions
RADIATIONhypofraction
70 Gy in 28 fractions over 5.6 weeks
RADIATIONconvention
80Gy in 40 fractions over 8 weeks
Sponsors
Beijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age 50-79 * Histologically confirmed prostate adenocarcinoma * Clinical stage T1-3N0M0 according to the AJCC 6th edition * Gleason score must be \>5 * KPS \>70 * No radical surgery or cryosurgery for prostate cancer
Exclusion criteria
* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible) * Evidence of distant metastases * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * Previous or concurrent cytotoxic chemotherapy for prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical progression free survival | up to 18 months | Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0 | From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT |
| Time to late grade 2+ adverse events as assessed by NCI CTCAE v. 4.0 | From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT |
| Overall Survival | up to 5 years |
Countries
China
Contacts
Primary ContactQiuzi Zhong
Outcome results
None listed