500 Participants Needed

Ultra-Hypo vs Conventional IMRT for Prostate Cancer

(PCS-XI Trial)

Recruiting at 11 trial locations
AM
JA
Overseen ByJosee Allard
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: CHU de Quebec-Universite Laval
Must be taking: ADT
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ultra-Hypo vs Conventional IMRT for Prostate Cancer?

Research shows that high-dose-rate brachytherapy (HDR-BT) and ultrahypofractionated radiation therapy, like stereotactic body radiotherapy (SBRT), are effective in treating prostate cancer by delivering higher doses of radiation in fewer sessions, which can improve outcomes without increasing side effects.12345

Is Ultra-Hypo Fractionated Radiotherapy safe for prostate cancer treatment?

Ultra-Hypo Fractionated Radiotherapy (UHF) for prostate cancer has been studied for safety, showing that lower doses (L-UHF) have a good balance between safety and effectiveness, with fewer side effects compared to higher doses (H-UHF). However, higher doses can lead to more gastrointestinal and urinary side effects.14678

How does Ultra-Hypo Fractionated Radiotherapy differ from other prostate cancer treatments?

Ultra-Hypo Fractionated Radiotherapy (UHF) for prostate cancer is unique because it delivers higher doses of radiation in fewer sessions compared to conventional methods, potentially reducing treatment time while maintaining similar effectiveness and safety. This approach combines Intensity-Modulated Radiation Therapy (IMRT) with a High-Dose Rate Brachytherapy (HDR-BT) boost, which allows for precise targeting of the cancer with minimal impact on surrounding healthy tissue.1591011

Research Team

AM

Andre-Guy Martin, MD MSc FRCPC

Principal Investigator

Andre-Guy Martin MD Inc.

Eligibility Criteria

This trial is for men with a specific type of prostate cancer that hasn't spread to other parts of the body. They should be at an intermediate to very high risk according to NCCN guidelines and have not had pelvic radiotherapy before. Men with autoimmune diseases like Lupus, past inflammatory bowel disease, advanced prostate cancer (stage M1), severe urinary symptoms even on medication, or bilateral hip replacements cannot join.

Inclusion Criteria

My cancer has not spread to distant parts of my body.
My condition is classified as intermediate to very high risk.
My cancer has a risk of spreading to lymph nodes needing pelvic radiation.
See 2 more

Exclusion Criteria

I have a history of autoimmune diseases like Lupus.
I have a history of inflammatory bowel disease.
My cancer has spread to other parts of my body.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ultra-hypo fractionated radiotherapy (5 Gy/fraction) over 2 weeks or standard fractionation (1.8-2.15 Gy/fraction) over 4-5 weeks, combined with HDR brachytherapy and ADT

2-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments every 3 months for 1 year, then every 6 months up to 36 months, and annually up to 10 years

10 years

Long-term Monitoring

Long-term monitoring of testosterone levels and other health metrics to assess disease-free survival and overall survival

10 years

Treatment Details

Interventions

  • Conventionally Fractionated IMRT with HDR Boost
  • HDR Prostate +/- Adjacent Seminal Vesicles Brachytherapy Boost (HDR-BT)
  • Pelvic Nodes Ultra-Hypo Fractionated Radiotherapy (UHF)
Trial OverviewThe study compares two types of radiation therapy: ultra-hypo fractionated radiotherapy delivering higher doses per session versus standard or moderate hypo-fractionation with lower doses per session. Both methods are combined with HDR brachytherapy boost and hormone therapy as per NCCN guidelines. The main goal is to see if the new method is just as good without causing more side effects.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ultra hypo fractionation radiation therapy (UHF)Experimental Treatment8 Interventions
5 radiation treatments (5 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given every other day over 2 weeks for a total of 25 Gy.
Group II: standard of care fractionation (SOC)Active Control8 Interventions
20-25 radiation treatments (range: 1,8 to 2,15 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given in 20-25 working day treatments over 4-5 weeks for a total of 43 Gy to 46 Gy.

Conventionally Fractionated IMRT with HDR Boost is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Intensity-Modulated Radiation Therapy with High-Dose Rate Brachytherapy Boost for:
  • Prostate cancer
🇪🇺
Approved in European Union as IMRT with HDR-BT for:
  • Prostate cancer
🇨🇦
Approved in Canada as Intensity-Modulated Radiation Therapy with High-Dose Rate Brachytherapy Boost for:
  • Prostate cancer
🇯🇵
Approved in Japan as IMRT with HDR-BT for:
  • Prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials
177
Recruited
110,000+

TerSera Therapeutics LLC

Industry Sponsor

Trials
11
Recruited
1,300+

Findings from Research

High-dose-rate brachytherapy (HDR-BT) delivers a significantly higher dose to the planning target volume (PTV) compared to both robotic and conventional stereotactic body radiotherapy (SBRT), indicating its potential for more effective treatment of prostate cancer.
HDR-BT results in lower radiation exposure to the bladder and rectum than SBRT, which may reduce the risk of side effects, although it does expose the urethra to a higher dose.
Treatment planning comparison of high-dose-rate brachytherapy vs. robotic and conventional stereotactic body radiotherapy for ultrahypofractionated treatment of prostate cancer.Yoshioka, Y., Sasamura, K., Ito, M., et al.[2023]
In a study of 148 prostate cancer patients treated with high-dose-rate (HDR) brachytherapy followed by intensity-modulated radiation therapy (IMRT), the treatment showed a high 4-year biochemical disease-free survival (bDFS) rate of 96.8% using the Phoenix criteria.
The treatment was well tolerated, with low rates of genitourinary (10%) and gastrointestinal (5%) toxicities, indicating that this combination therapy is both effective and safe for patients in a community setting.
Four-year outcomes of hypofractionated high-dose-rate prostate brachytherapy and external beam radiotherapy.Chen, WC., Tokita, KM., Ravera, J., et al.[2018]
In a study of 78 high-risk prostate cancer patients, treatment with normofractionated whole pelvic radiotherapy followed by a hypofractionated boost using intensity-modulated radiotherapy (IMRT) showed excellent tolerance, with only 1% experiencing severe acute toxicity and no patients reporting grade 4 toxicity.
With a median follow-up of 57 months, the treatment resulted in high rates of disease control, including an 84.5% biochemical disease-free survival rate, indicating that this approach is effective for managing non-metastatic prostate cancer at high risk of lymph node involvement.
Hypofractionated external beam radiotherapy to boost the prostate with ≥85 Gy/equivalent dose for patients with localised disease at high risk of lymph node involvement: feasibility, tolerance and outcome.Zilli, T., Jorcano, S., Escudé, L., et al.[2018]

References

Treatment planning comparison of high-dose-rate brachytherapy vs. robotic and conventional stereotactic body radiotherapy for ultrahypofractionated treatment of prostate cancer. [2023]
Four-year outcomes of hypofractionated high-dose-rate prostate brachytherapy and external beam radiotherapy. [2018]
Hypofractionated external beam radiotherapy to boost the prostate with ≥85 Gy/equivalent dose for patients with localised disease at high risk of lymph node involvement: feasibility, tolerance and outcome. [2018]
A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer. [2023]
The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]
A comparison of HDR brachytherapy and IMRT techniques for dose escalation in prostate cancer: a radiobiological modeling study. [2022]
Stereotactic body radiotherapy for prostate cancer: treatment approaches and clinical outcomes. [2020]
Ultrahypofractionated Radiotherapy versus Conventional to Moderate Hypofractionated Radiotherapy for Clinically Localized Prostate Cancer. [2022]
Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Long-Term Outcomes of a Prospective Study on Highly Hypofractionated Intensity Modulated Radiation Therapy for Localized Prostate Cancer for 3 Weeks. [2023]
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial. [2021]