Phase II Study to Evaluate Conventional Radiation Therapy Followed by Radiosurgical Boost in Clinically Localized Prostate Cancer

Georgetown University

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy with IMRT and CyberKnife Boost

Study type: Interventional

Funder types: Other

Identifiers

NCT01618851

IRB 2009-599

Details and patient eligibility

About

This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy in 25 fractions).

Full description

This is a phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per fraction to the PTV) followed by IMRT (45 Gy in 25 fractions). Treatment will be completed over a 6-7 week period.

The hypothesis is that for patients with clinically localized adenocarcinoma of the prostate, CyberKnife Radiosurgery delivered to the prostate is efficacious with acceptable toxicity in combination with IMRT.

Subjects will have toxicity evaluation and AUA score on the last day of treatment. At 1 month following treatment, subjects will be assessed for acute toxicity and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18 and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), subjects will be seen and evaluated, including a history, physical exam, performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure. A bone scan will be performed at the time of biochemical failure, or when the subject develops signs of symptoms suggesting metastatic disease.

Acute side effects (≤ 90 days of treatment start) will be assessed using the NCI Toxicity Criteria version 3.0.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the prostate (Biopsy within one year of enrollment)
• Signed Study-Specific COnsent
• PSA within 60 days of registration
• Baseline AUA score is less than 20

Exclusion criteria

• Prior Pelvic radiotherapy
• Prior Radical Prostate surgery
• Recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer
• Medical or psychiatric illness that would interfere with treatment or follow-up
• Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

IMRT with SBRT Boost

Experimental group

Description:

Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per fraction to PTV) followed by IMRT (45 Gy in 25 fractions) over 6-7 weeks.

Treatment:

Radiation: Radiotherapy with IMRT and CyberKnife Boost