Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

Hospital Sirio-Libanes

Status: Unknown

Conditions: Prostatic Neoplasms

Treatments: Radiation: HypoIGRT

Study type: Observational

Funder types: Other

Identifiers

NCT02651896

HSL 2015-64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

130 participants in 1 patient group

HypoIGRT

Description:

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

Treatment:

Radiation: HypoIGRT