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

NCT01618851 | Unknown DMC

• 1 other identifier: IRB 2009-599
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• Local failure

  To estimate the rate of local failure as assessed by 2 year post-radiotherapy prostate biopsies. (Studies with the CyberKnife radiosurgery would be worthwhile for prostate cancer patients if the rate of local control was \> 70%)

  2 years after radiotherapy.

Secondary Outcomes (6)

• Gastrointestinal and genitourinary toxicity

  During 5 years following the CyberKnife SRS treatment for prostate cancer

• Biochemical disease-free survival (bDFS)

  2 years after radiotherapy

• Patient Reported Quality of Life: American Urological Association symptom index

  During the 5 years following radiotherapy

• Patient Reported Quality of Life: Expanded Prostate Cancer Index Composite-26 (EPIC-26)

  During the 5 years following radiotherapy

• Patient Reported Quality of Life: Sexual Health Inventory for Men (SHIM)

  During the 5 years following radiotherapy

Study Arms (1)

IMRT with SBRT Boost

EXPERIMENTAL

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.

Radiation: Radiotherapy with IMRT and CyberKnife Boost

Interventions

Radiotherapy with IMRT and CyberKnife Boost RADIATION

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. The prescribed PTV dose of 19.5 Gy shall be given in 3 fractions using the CyberKnife. At least three fiducials should be identified for each treatment. If fewer than three fiducials can be tracked, then additional fiducials will be placed, and the patient replanned. Fiducial locations in the images will be extracted and compared to the fiducial locations in the CT scans to estimate target movements. For IMRT, Daily doses of 180 cGy are to be delivered to the PTV 5 days a week to a total dose of 4500 cGy in 25 fractions.

IMRT with SBRT Boost

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead

Related Publications (1)

• Dess RT, Devasia TP, Aghdam N, Jackson WC, Soni PD, Smith CP, Mitchell AL, Suy S, Hamstra DA, Jolly S, Nguyen PL, Feng FY, Schipper MJ, Skolarus TA, Miller DC, Wittmann DA, Collins SP, Spratt DE. Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Jun 1;101(2):376-386. doi: 10.1016/j.ijrobp.2018.01.055. Epub 2018 Jan 31.

  PMID: 29487023 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• Sean P Collins, MD,PhD

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 13, 2012
• Study Start: November 1, 2009
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-02