Clinical trial NCT03380806: Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
Official title: A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stereotactic body radiotherapy (SBRT)
conventional radiotherapy (CRT)
High risk prostate cancer
quality of life (QoL)
The Expanded Prostate cancer Index Composite (EPIC-26)
International Prostate Symptom Score (IPSS)
Lead sponsor: Juravinski Cancer Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2017-12-21
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.

Detailed description: In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.

Eligibility criteria: Inclusion Criteria:

* Histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage T3 or higher and/or Gleason score 8 or higher and/or initial PSA level above 20;)
* No radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and CT-scan of the abdomen and pelvis) or incidental findings (localized N0, M0 disease)
* Patient is able to complete the quality of life questionnaires in English.
* Informed consent obtained

Exclusion Criteria:

* • Histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date;
* Previous treatment for carcinoma of the prostate (other than biopsy or TURP), including bilateral orchiectomy;
* Patients previously on more than twelve weeks of hormone therapy for their PrCa;
* Past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years;
* Contraindications to placement of gold seeds for daily prostate localization;
* Previous pelvic RT and/or significant pelvic surgery;
* Severe diverticular or inflammatory bowel disease (as determined by the treated radiation oncologist)
* Previous hip replacement
* PSA over 50
* IPSS 20 or higher
* TRUS-based prostate
* volume of \> 80 cc

Primary outcomes:
measure: Short Term Quality of Life (QoL)
timeFrame: up to 6 months post radiation
Secondary outcomes:
measure: Long Term Quality of Life (QoL)
timeFrame: 24 months
measure: Urinary function assessment
timeFrame: 24 months
measure: Late Toxicity
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: St. Catharines
country: Canada
facility: Walker Family Cancer Centre ,Niagara Health - St. Catharines Site
state: Ontario
Study officials:
References: