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Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01976962
Enrollment
20
Registered
2013-11-06
Start date
2018-01-10
Completion date
2021-11-25
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

Prostatic neoplasms, Radiotherapy, Dose fractionation, Magnetic resonance imaging

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.

Interventions

RADIATIONStereotactic body RT with MR-guided boost

Patients will receive radiotherapy over 5 fractions delivered once per week over 29 days, with 7.25 Gy per fraction to the whole prostate and 8 Gy per fraction to the dominant intraprostatic lesion. There will be a minimum of 120 hours and maximum of 192 hours between fractions. The entire course of treatment should be completed within no less than 27 days and no longer than 30 days.

Sponsors

CancerCare Manitoba
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life as per EPIC6 monthsExpanded Prostate Cancer Index Composite (EPIC) bowel domain

Secondary

MeasureTime frameDescription
Quality of Life as per EPIC and SF-12Up to 5 yearsExpanded Prostate Cancer Index Composite (EPIC) questionnaire (other domains) and Medical Outcomes Study Short-Form 12 (SF-12) v2
GU and GI ToxicityUp to 5 yearsRTOG and CTCAE v4.0 genitourinary and gastrointestinal toxicities
Biochemical failure5 yearsPhoenix defined (nadir PSA + 2 ng/mL) biochemical failure
Pathologic response3 yearsPathologic presence of malignancy on biopsy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026