Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

• Conditions: Prostatic Neoplasms
• Interventions: Radiation: HypoIGRT

• Registration Number: NCT02651896
• Lead Sponsor: Hospital Sirio-Libanes

Brief Summary

Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:

1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or

2. Improving tumour control, mainly freedom from biochemical failure survival.

Detailed Description

The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.

Primary Outcome Measures:

1. Acute and late radiation induced toxicities.

Secondary Outcome Measures:

1. Freedom from prostate cancer recurrence - freedom from biochemical failure survival;

2. Cause specific and overall survival

3. Aspects of quality of life and health economics

Study Design:

Allocation: Prospective allocation Endpoint Classification: Feasibility Study (Toxicity assessment) Intervention Model: Single Assignment Masking: Open Label Primary Purpose: Treatment

Eligibility

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Study Population:

Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.

Study Timeline

• Study Start: 2015-12-20
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25
• Primary Completion: 2018-07-01
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
2. Patients older than 18 years old
3. Patients who accept to perform follow up in the radiation oncology department
4. Performance Status ≥ 70
5. Written informed consent

Exclusion Criteria

1. Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment
2. Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HypoIGRT	HypoIGRT	1. Low Risk (T1-T2a, Gleason score 6, and PSA \< 10 ng/mL) 2. Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL) 3. High Risk (T3 - 4 , Gleason 8-10, and/or PSA \> 20 ng/mL) Neoadjuvant hormone therapy is allowed on groups 2 and 3

Primary Outcome Measures

Name	Time	Method
Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.	During and up to 90 days after treatment ends (acute event)	According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Overall Acute Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.	During and up to 90 days after treatment ends (acute event)	According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Overall Late Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.	After 90 days up to 24 months from treatment (late event)	According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
Overall Late Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.	After 90 days up to 24 months from treatment (late event)	According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.

Secondary Outcome Measures

Name	Time	Method
Freedom from biochemical failure survival	12 and 24 months	Prostate-Specific Antigen (PSA) values
Overall Survival	12 and 24 months	Defined as the percentage of participant on treatment group who are alive at 12 and 24 months after the start of treatment.
Cause specific Survival	12 and 24 months	Defined as the cancer survival in the absence of other causes of death at 12 and 24 months after the start of treatment.
Quality of life	12 and 24 months	The Expanded Prostate Cancer Index Composite (EPIC) - Brazilian Portuguese version.; will be applied to assess urinary, bowel and sexual functions.

Trial Locations

Locations (1)

Hospital Sírio-Libanes; 🇧🇷 São Paulo, SP, Brazil