Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

Sergio Faria

Status: Completed

Conditions: High Risk Prostate Cancer

Treatments: Radiation: IMRT Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02107287

11-519 GEN

Details and patient eligibility

About

Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.

Enrollment: 105 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
• Clinical Stage >T3 or
• Gleason Score 8 or higher, or
• PSA level >20ng/ml
• Study entry PSA must be obtained within 6 weeks prior to protocol entry
• ECOG <2
• Age >18
• History and physical examination within 3 months
• Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative.
• CBC with differential within 6 weeks prior to protocol entry
• Absolute neutrophil count >2000cells/mm3
• Hemoglobin >8.0 g/dl (the use of transfusion to increase the Hg is acceptable)
• Testosterone level within 6 weeks of protocol entry
• Liver function tests
• Signed informed consent
• Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months.

Exclusion criteria

• Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
• Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
• Prior radiotherapy to the pelvis
• Life expectancy of less than 2 years.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

IMRT Hypofractionated

Experimental group

Description:

Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy.

Treatment:

Radiation: IMRT Technique