Clinical trial NCT01976962: Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer
Official title: Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Prostatic neoplasms
Radiotherapy
Dose fractionation
Magnetic resonance imaging
Lead sponsor: CancerCare Manitoba
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 20
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: To improve radiation therapy of prostate cancer, the investigators must be able to accurately identify the tumour. By using advanced functional imaging techniques available on state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the prostate, the investigators can use advanced radiation therapy techniques to specifically target the tumor and control it with as few radiotherapy clinic visits as possible. This is different than current techniques which treat the whole prostate gland to the same dose, delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to the active tumor while still maintaining adequate radiation dose to the rest of the prostate, the investigators hope to better control prostate cancer and reduce complications to nearby normal tissues.

Detailed description: This project combines advances in functional imaging of prostate cancer and hypofractionation through stereotactic body radiotherapy (SBRT), with an aim to improve tumour control and reduce or maintain normal tissue complications. The strategy will make use of the combined effectiveness of several functional imaging approaches to identify the dominant lesion(s) within the prostate. An SBRT treatment plan will be designed which utilizes 5 fractions to treat the entire prostate gland with an additional boost to the dominant lesion. The lower dose to the entire prostate should reduce normal tissue complications but still be effective in treating prostate cancer while the increased dose to the dominant lesion should improve tumour control. The use of only 5 fractions will reduce the number of patient visits, thus reducing overall treatment costs.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age \>18 years
* Histologically confirmed and centrally reviewed prostate adenocarcinoma based
* PSA within 60 days
* High risk prostate cancer defined as any one of: clinical stage \>= T3, Gleason score \>= 8, or PSA \>=20 and \<50 ng/mL.

Exclusion Criteria:

* Evidence of lymph node metastasis
* Evidence of distant metastases
* Prior pelvic radiotherapy or brachytherapy
* Previous radical prostatectomy, cryotherapy, or high-frequency ultrasound
* Unable to undergo gold seed insertion
* Immunosuppressive medications
* Inflammatory bowel disease
* Unable to undergo MRI
* Previous bilateral orchiectomy
* Previous hormonal therapy including LHRH agonists (leuprolide, goserelin), LHRH antagonists (degarelix), anti-androgens (bicalutamide, flutamide, nilutamide), surgical castration, and estrogens
* Previous finasteride within 14 days.
* Previous dutasteride within 180 days.

Primary outcomes:
measure: Quality of Life as per EPIC
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life as per EPIC and SF-12
timeFrame: Up to 5 years
measure: GU and GI Toxicity
timeFrame: Up to 5 years
measure: Biochemical failure
timeFrame: 5 years
measure: Pathologic response
timeFrame: 3 years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
Study officials:
affiliation: CancerCare Manitoba
name: Aldrich Ong, MD
role: PRINCIPAL_INVESTIGATOR
References: