Tumor TARGET Prostate Cancer

NCT01802242 | Active Not Recruiting DMC

• 1 other identifier: UHN REB 12-5015-C
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Prostate tumour; Prostate radiotherapy; prostate cancer treatment

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (9)

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

  5 years

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

  5 years

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

  5 years

• Compare dose to recurrent and non-recurrent tumor nodules.

  5 years

• Determine rates of toxicity with tumor-targeted boost radiotherapy.

  5 years

Other Outcomes (2)

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

  5 years

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

  5 years

Study Arms (2)

Active Radiation Treatment (Cohort 2)

EXPERIMENTAL

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

Prior Radiation Treatment (Control Cohort)

OTHER

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

Other: No Active Treatment - completed Prior Radiation

Interventions

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

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

Active Radiation Treatment (Cohort 2)

No Active Treatment - completed Prior Radiation OTHER

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

Prior Radiation Treatment (Control Cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

University Health Network, The Princess Margaret

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics

Study Officials

• Peter Chung, MB ChB

  University Health Network, The Princess Margaret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: March 1, 2013
• Study Start: October 1, 2012
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CA (1)