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Tumor Targeted Radiotherapy for Patients With Localized Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Patients With Prostate Cancer.

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Trial Information

Tumor Targeted Radiotherapy for Patients With Localized Prostate Cancer

This is a prospective two arm phase 2 trial investigating the technical and clinical
performance of tumor-targeted (rather than prostate targeted) radiotherapy.

Cohort 1 (Control group): This group consists of patients who have had previous radiation.
This group will not receive any active treatment but will have a biopsy at 3 years from the
time they completed their radiation therapy. Patient in this group will also continue to
have their PSA checked per standard practice

Cohort 2 (Experimental group): Patients in this group will receive one of 2 treatment arms
of their choice. In addition to the MRI-guided prostate biopsy at 3 years and regular
standard of care PSA checks, this group will also complete a quality of life questionnaire
and have regular imaging per standard practice.

Both groups will be followed by the research team per protocol.

Inclusion Criteria

Inclusion Criteria [applicable to both Cohorts 1 (control) and Cohort 2 (Experimental)
unless otherwise specified]:

1. Histological evidence of prostate adenocarcinoma.

2. Discrete intra‐prostatic tumor that can be confidently visualized on MRI prior to
radiotherapy (>5mm maximum diameter but <33% of prostate volume, biopsy confirmed)

3. At least 18 years old

4. ECOG performance status 0 or 1 with > 10‐year life expectancy

5. Informed consent: All patients must sign a document of informed consent indicating
their understanding of the investigational nature and risks of the study before any
protocol related studies are performed (this does not include standard care
laboratory tests or imaging studies).

6. Patients will be one of the following risk groups prior to therapy:

- Low‐risk disease (Gleason 6 and PSA <10 and T1) AND >50% of biopsy cores
involved with tumor

- Intermediate‐risk disease (Gleason 7 or PSA 10‐20 or T2)

- High‐risk disease (Gleason >8 or T3 or PSA >20)

7. Risk of LN involvement <30% (Roach formula = 2/3PSA([G‐6]x10))

8. Patients who received 78Gy RT to the prostate gland 3‐4.5 years prior to enrollment
(Cohort 1 only)

Exclusion Criteria [applicable to both Cohorts 1 (control) and Cohort 2(Experimental)
unless otherwise specified]:

1. Previous history of radiation therapy to the prostate (Cohort 2)

2. Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2)

3. Patients weighing >136kgs (weight limit for the scanner tables)

4. Patients with contraindications to MRI: this includes patients with pacemakers,
cerebral aneurysm clips, shrapnel injury or implantable electronic devices not
compatible with MRI determination. Exceptions will be allowed if deemed sage and
appropriate by the MRI technologist.

5. Severe claustrophobia

6. Bleeding diathesis and anti‐coagulative therapy that cannot be temporarily ceased
precluding biopsy

7. Current hormonal therapy (Cohort 1) or initiated >2 weeks prior to enrollment (Cohort

8. Radiological evidence of regional or distant metastases (Cohort 2)

9. Other urinary or medical conditions deemed by the PI or associates to make the
patient ineligible for MRI‐guided prostate biopsy

10. Contraindications to the endorectal coil, surgically absent rectum, severe
hemorrhoids or previous colorectal surgery

11. Contraindications to conscious sedation

12. Latex allergy

13. History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort

14. Other medical conditions deemed by the PI to make patient ineligible for study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine rates of Local Control after standard targeted boost radiotherapy in patients with localized prostate cancer.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Cynthia Ménard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, The Princess Margaret


Canada: Ethics Review Committee

Study ID:

UHN REB 12-5015-C



Start Date:

October 2012

Completion Date:

October 2015

Related Keywords:

  • Patients With Prostate Cancer.
  • Prostate Cancer
  • Prostate tumour
  • Prostate radiotherapy
  • prostate cancer treatment
  • Prostatic Neoplasms