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Tumor TARGET Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy

No Active Treatment - completed Prior Radiation

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Prostate tumour, Prostate radiotherapy, prostate cancer treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Histological evidence of prostate adenocarcinoma.
Discrete intra-prostatic tumor that can be confidently visualized on MRI prior to radiotherapy (>5mm maximum diameter but <33% of prostate volume, biopsy confirmed from initial diagnosis or interventional Biopsy) )
At least 18 years old
ECOG performance status 0 or 1 with > 10-year life expectancy
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).
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)
Risk of LN involvement <30% (Roach formula = 2/3PSA([G-6]x10))
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]:

Previous history of radiation therapy to the prostate (Cohort 2)
Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2)
Patients weighing >136kgs (weight limit for the scanner tables)
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.
Severe claustrophobia
Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy
Current hormonal therapy (Cohort 1) or initiated >2 weeks prior to enrollment (Cohort 2)
Radiological evidence of regional or distant metastases (Cohort 2)
Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy
Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
Contraindications to conscious sedation
Latex allergy
History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2)
Other medical conditions deemed by the PI to make patient ineligible for study intervention

Sites / Locations

University Health Network, The Princess Margaret

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Active Radiation Treatment (Cohort 2)

Prior Radiation Treatment (Control Cohort)

Arm Description

Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment. This group will not be receiving any active treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Determine if high-dose tumor-targeted radiotherapy for localized prostate cancer can be integrated in a standard-care workflow.

Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost

Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy

Compare dose to recurrent and non-recurrent tumor nodules.

Determine rates of toxicity with tumor-targeted boost radiotherapy.

Assess Quality of Life (QoL) outcomes after high-dose tumor-targeted boost therapy.

Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques

Determine clinical outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.

Determine dosimetric outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.

Full Information

NCT ID

NCT01802242

First Posted

October 22, 2012

Last Updated

May 7, 2023

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

1. Study Identification

Unique Protocol Identification Number

NCT01802242

Brief Title

Tumor TARGET Prostate Cancer

Official Title

Tumor Targeted Radiotherapy for Patients With Localized Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Prostate cancer is common in males and may develop over the course of an individual's life. This cancer is often discovered at the time of routine physical examinations and/or blood work or on rectal examination. Once diagnosed, most patients do require some form of treatment so that the prostate cancer does not progress to cause damage and/or shortened lifespan. Occasionally, after patients receive treatment, the investigators have found that an area of cancer remains within the prostate. Those patients with a large area of cancer (i.e. seen on MRI image) appear to have a higher chance of remaining or recurrent prostate cancer even after standard treatment. Thus, the investigators believe that the area of the prostate gland occupied by a dense area of cancer may need more radiation therapy than normal to remain cancer free. Standard therapy currently in place in North America: Currently patients who are diagnosed with prostate cancer have 3 common options: surgery, external beam radiation therapy (EBRT) alone or internal radiation (brachytherapy). Patients may or may not receive hormone therapy alongside the radiation depending on their physician's preference. For those who receive radiation therapy, the tumor typically receives the same dose as the rest of the prostate gland. Findings to date: In the past few years the investigators have discovered that patients with a tumor large enough to be seen on MRI images (>5mm) have a higher chance than normal of having cancer remain in the prostate, despite receiving treatment for their cancer 3 years earlier. Using new technology investigators can deliver radiation therapy after viewing the prostate tumor on MRI. This guides therapy, allowing the radiation treatment to be targeted to the tumor within the prostate. Based on this earlier success the investigators believe that they can now safely give a higher dose of radiation to specifically target the cancer within the prostate gland. Reason for the study: The investigators would like to test this technology and expertise to give radiation to a higher than normal dose to the tumor nodule in prostate gland.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer, Prostate tumour, Prostate radiotherapy, prostate cancer treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Radiation Treatment (Cohort 2)

Arm Type

Experimental

Arm Title

Prior Radiation Treatment (Control Cohort)

Arm Type

Other

Arm Description

Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment. This group will not be receiving any active treatment

Intervention Type

Radiation

Intervention Name(s)

Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy

Intervention Description

Patients in this group will receive one of 2 treatment arms of their choice: Arm 1: VMAT delivery with integrated VMAT boost (IB-VMAT) GTV: 95Gy in 38fractions Arm 2: HDR-boost followed by VMAT GTV: 10Gy HDR + 76Gy in 38 fractions VMAT

Intervention Type

Other

Intervention Name(s)

No Active Treatment - completed Prior Radiation

Intervention Description

Already had prior radiation treatment. MRI-guided prostate biopsy at 3 years and PSA per standard practice

Primary Outcome Measure Information:

Title

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Determine if high-dose tumor-targeted radiotherapy for localized prostate cancer can be integrated in a standard-care workflow.

Time Frame

5 years

Title

Determine a methodology with appropriate uncertainty margins for Gross Tumour Volume boost

Time Frame

5 years

Title

Evaluate the spatial distribution of prostatic carcinoma at the time of repeat biopsy

Time Frame

5 years

Title

Compare dose to recurrent and non-recurrent tumor nodules.

Time Frame

5 years

Title

Determine rates of toxicity with tumor-targeted boost radiotherapy.

Time Frame

5 years

Title

Assess Quality of Life (QoL) outcomes after high-dose tumor-targeted boost therapy.

Time Frame

5 years

Title

Determine patient acceptance of combination of high dose rate and volumetric modulated arc therapy techniques

Time Frame

5 years

Title

Determine clinical outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.

Time Frame

5 years

Title

Determine dosimetric outcomes by comparing integrated boost volumetric modulated arc therapy and a combination of high dose rate and volumetric modulated arc therapy techniques.

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Explore the predictive value of baseline and early response imaging biomarkers on Local Control.

Time Frame

5 years

Title

Bank tissue and biofluids for future exploration of the relationship between biopsy tissue/serum/urine and disease recurrence.

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria [applicable to both Cohorts 1 (control) and Cohort 2 (Experimental) unless otherwise specified]: Histological evidence of prostate adenocarcinoma. Discrete intra-prostatic tumor that can be confidently visualized on MRI prior to radiotherapy (>5mm maximum diameter but <33% of prostate volume, biopsy confirmed from initial diagnosis or interventional Biopsy) ) At least 18 years old ECOG performance status 0 or 1 with > 10-year life expectancy 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). 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) Risk of LN involvement <30% (Roach formula = 2/3PSA([G-6]x10)) 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]: Previous history of radiation therapy to the prostate (Cohort 2) Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2) Patients weighing >136kgs (weight limit for the scanner tables) 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. Severe claustrophobia Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy Current hormonal therapy (Cohort 1) or initiated >2 weeks prior to enrollment (Cohort 2) Radiological evidence of regional or distant metastases (Cohort 2) Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery Contraindications to conscious sedation Latex allergy History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2) Other medical conditions deemed by the PI to make patient ineligible for study intervention

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Chung, MB ChB

Organizational Affiliation

University Health Network, The Princess Margaret

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network, The Princess Margaret

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

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Tumor TARGET Prostate Cancer

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