IG-VMAT for Localized Prostate Cancer

Beijing Hospital

Status and phase: Unknown; Phase 3

Conditions: Prostate Cancer

Treatments: Radiation: convention; Radiation: hypofraction

Study type: Interventional

Funder types: Other

Identifiers

NCT02934685

BeijingH-01-RT

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

hypofraction

Experimental group

Description:

70 Gy in 28 fractions over 5.6 weeks

Treatment:

Radiation: hypofraction

convention

Active Comparator group

Description:

80Gy in 40 fractions over 8 weeks

Treatment:

Radiation: convention