2 Ablative RadioTherapy Treatments for Prostate Cancer

NCT04654338 | Recruiting Phase 2 DMC

• 1 other identifier: 3592
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Acute Toxicities

  Acute GU and GI toxicities according to the NCI CTCAE v4.0

  6 months

Secondary Outcomes (3)

• Late Toxicities

  5 years

• QOL

  5 years

• PSA

  5 years

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Radiation: SABR + HDR

Interventions

SABR + HDR RADIATION

One SABR treatment + one HDR brachytherapy treatment

Intervention Arm

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate
• Favorable risk disease defined as either:
• Low risk disease: T1-T2c, grade group 1, PSA \< 10 ng/ml or
• Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity \> 50%
• Prostate volume \< 60 cc as determined by US, CT or MRI
• Ability to undergo MR imaging
• Provide written informed consent

You may not qualify if:

• Documented nodal or distant metastases
• Previous pelvic radiotherapy
• Previous transurethral resection of prostate, previous prostatectomy or HIFU
• Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
• Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>15
• Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
• Significant medical co-morbidity rendering patient unsuitable for general anaesthesia

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

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; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrew Loblaw, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merrylee McGuffin, MSc

CONTACT

416-480-6100; Merrylee.Mcguffin@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GU Radiation Oncology Site Group Lead

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 4, 2020
• Study Start: July 29, 2020
• Primary Completion: January 29, 2024
• Study Completion (Estimated): July 29, 2028
• Last Updated: June 27, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)