Clinical trial NCT01618851: Phase II Study to Evaluate Conventional Radiation Therapy Followed by Radiosurgical Boost in Clinically Localized Prostate Cancer
Official title: Phase II Study to Evaluate the Efficacy of Intensity Modulated Radiation Therapy With Hypofractionated Radiosurgical Boosts in the Treatment of Clinically Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local failure
timeFrame: 2 years after radiotherapy.
Secondary outcomes:
measure: Gastrointestinal and genitourinary toxicity
timeFrame: During 5 years following the CyberKnife SRS treatment for prostate cancer
measure: Biochemical disease-free survival (bDFS)
timeFrame: 2 years after radiotherapy
measure: Patient Reported Quality of Life: American Urological Association symptom index
timeFrame: During the 5 years following radiotherapy
measure: Patient Reported Quality of Life: Expanded Prostate Cancer Index Composite-26 (EPIC-26)
timeFrame: During the 5 years following radiotherapy
measure: Patient Reported Quality of Life: Sexual Health Inventory for Men (SHIM)
timeFrame: During the 5 years following radiotherapy
measure: Patient Reported Quality of Life: Utilization of Sexual Medications and Devices
timeFrame: During the 5 years following radiotherapy
Other outcomes:
Locations:
Study officials:
affiliation: Georgetown University Hospital
name: Sean P Collins, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.