ARGOS/CLIMBER: PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05269550

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: High Intermediate Risk Patients Radiation: High Risk or Very High-Risk Patients	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PSMA MRI Guided Prostate SBRT(ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)

Actual Study Start Date :

May 3, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Men with high intermediate to very high risk protstate cancer	Radiation: High Intermediate Risk Patients 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 start of radiotherapy (concurrent plus adjuvant) Radiation: High Risk or Very High-Risk Patients 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 start of radiotherapy (concurrent plus adjuvant)

Arm

Intervention/Treatment

Experimental: Men with high intermediate to very high risk protstate cancer

Radiation: High Intermediate Risk Patients

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 start of radiotherapy (concurrent plus adjuvant)

Radiation: High Risk or Very High-Risk Patients

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 start of radiotherapy (concurrent plus adjuvant)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life [5 years]
Quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires.
Disease Free Survival [5 years]
Five-year disease-free survival (DFS) as a composite of biochemical control, patient death or development of clinical metastases or institution of salvage ADT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Centre	London	Ontario	Canada	N6A 5W9

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Glenn Bauman, Principle Investigator, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT05269550

Other Study ID Numbers:

ARGOS/CLIMBER

First Posted:

Mar 8, 2022

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Glenn Bauman, Principle Investigator, Lawson Health Research Institute

High intermediate risk prostate cancer

High-risk prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of May 10, 2022