IG-VMAT for Localized Prostate Cancer

Phase 3

• Conditions: Prostate Cancer
• Interventions: Radiation: convention; Radiation: hypofraction

• Registration Number: NCT02934685
• Lead Sponsor: Beijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18
• Primary Completion: 2017-02
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
convention	convention	80Gy in 40 fractions over 8 weeks
hypofraction	hypofraction	70 Gy in 28 fractions over 5.6 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall Survival	up to 5 years
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

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, China