NCT05269550

Brief Summary

This study is a prospective Phase I/II protocol enrolling men with either high intermediate-risk or high-risk or very high-risk prostate cancer. All men will have PSMA Targeted PET (using the PSMA targeting ligand PSMA 1007) and multiparametric magnetic resonance imaging (mpMRI) for delineation of intra-prostatic foci of cancer and any involved regional lymph nodes based on high SUV uptake on PET or mpMRI (T2W, DWI/ADC, DCE) appearance suspicious for cancer. Tumour delineation will be performed by fusing the PSMA PET and mpMRI with planning CT simulation images. Fiducial marker implantation for treatment guidance will be mandatory but use of other organs at risk protection strategies (i.e. GU Loc, Space-OAR) will be allowed but not mandatory. Patients will be treated with image-guided SBRT using the fiducial markers for intra-fraction motion management. Dose escalation to imaging defined targets (intra-prostatic and involved nodes on PSMA PET + MRI) will be accomplished through a simultaneous boost technique. Maintaining dose to organs at risk will take precedence over boost dose targets (targeted maximum dose of 50Gy/5 fractions to imaging defined prostatic lesion; 35Gy/5 fractions to imaging defined involved nodes). Cohort extension: We hypothesize that integration of neoadjuvant androgen deprivation therapy will provide for pretreatment cancer downstaging and will allow us to achieve higher target doses to the imaging defined DILs than currently achieve. Additionally, we plan to include a novel sodium MRI protocol into the baseline imaging to compare DIL volumes delineated by this modality to those by mpMRI and PSMA PET and to characterize changes in sodium MRI in response to ADT alone and subsequent radiotherapy

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
32mo left

Started May 2022

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2022Dec 2028

First Submitted

Initial submission to the registry

January 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2022

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2028

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

6.6 years

First QC Date

January 12, 2022

Last Update Submit

July 24, 2025

Conditions

Prostate Cancer

Keywords

High intermediate risk prostate cancerHigh-risk prostate cancer

Outcome Measures

Primary Outcomes (3)

  • 6-month Toxicity

    6-month gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

    6-months

  • 6-week Toxicity

    6-week gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

    6-weeks

  • Expansion cohort: Median minimum dose to dominant intra-prostatic lesion

    Expansion cohort: Median minimum dose to dominant intra-prostatic lesion

    6-months

Secondary Outcomes (2)

  • Quality of Life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires

    5 years

  • Disease Free Survival

    5 years

Other Outcomes (5)

  • Translational Endpoint 1

    24 months

  • Translational Endpoint 2

    24 Months

  • Translational Endpoint 3

    2 years

  • +2 more other outcomes

Study Arms (1)

Men with high intermediate to very high risk prostate cancer

EXPERIMENTAL

Men with high intermediate to very high risk prostate cancer

Radiation: High-Intermediate Risk Patients-cohort 1Radiation: High Risk or Very High-Risk Patients-cohort 1Radiation: High-Intermediate Risk Patients-cohort 2Radiation: High Risk or Very High-Risk Patients-cohort 2

Interventions

High-Intermediate Risk Patients-cohort 1RADIATION

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Six months of androgen deprivation therapy will commence with the end of radiotherapy (concurrent plus adjuvant)

Men with high intermediate to very high risk prostate cancer
High Risk or Very High-Risk Patients-cohort 1RADIATION

Patients will receive 35Gy/5 fractions to the whole prostate (25Gy to whole Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Pelvic lymph nodes will receive 25Gy/5 fractions synchronous with prostate treatment with a simultaneous boost to imaging involved nodes to a maximum of 35Gy/5 fractions. Eighteen months of androgen deprivation therapy will commence with the end of radiotherapy (concurrent plus adjuvant)

Men with high intermediate to very high risk prostate cancer
High-Intermediate Risk Patients-cohort 2RADIATION

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Androgen deprivation therapy will commence 3 months before radiotherapy (concurrent plus adjuvant) and will continue for a total of 6 months.

Men with high intermediate to very high risk prostate cancer
High Risk or Very High-Risk Patients-cohort 2RADIATION

Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Androgen deprivation therapy will commence 3 months before radiotherapy (concurrent plus adjuvant) and will continue for a total of 18 months.

Men with high intermediate to very high risk prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years of age
  • Histologically confirmed carcinoma of the prostate
  • High-intermediate risk or high risk as defined by NCCN criteria:
  • High intermediate: 2 or 4 intermediate risk factors (T2B-T2C, Gleason GG 2 or 3, PSA 10-20) or GG 3 or intermediate risk with equal or \>50% biopsy core involvement
  • High-risk: one of T3a, Gleason GG 4 or 5, or PSA \>20 ng/ml
  • Very-high risk: one of primary Gleason Pattern 5, \>4 cores Grade Group 4 or 5, clinical T3b, or more than 1 high-risk feature
  • Conventional imaging (bone scan and abdominal pelvic computed tomography) negative for extra-pelvic nodal, skeletal or visceral metastases
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete EPIC questionnaires

You may not qualify if:

  • Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted
  • Men with clinical T4 disease are excluded
  • Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Contraindication to prostate MRI (i.e. non0compatible stent, pacemaker, prosthesis, etc.)
  • Contraindication to use of PSMA PET agent PSMA 1007 due to intolerance or allergy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Poor baseline urinary function defined as a score of 5 ("big problem") on question 5 of the EPIC 26 (Overall, how big a problem has your urinary function been for you during the last 4 weeks?)
  • Definitive extra-pelvic nodal or distant metastatic disease on conventional staging investigations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

March 8, 2022

Study Start

May 3, 2022

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

December 15, 2028

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)