54 Participants NeededMy employer runs this trial

Radiotherapy for Prostate Cancer

(DESTINATION 2 Trial)

Recruiting at 2 trial locations
GB
SC
FM
Overseen ByFrancesca Mason
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Royal Marsden NHS Foundation Trust
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new radiotherapy approach for men with intermediate-risk, localized prostate cancer. It compares two methods of delivering radiotherapy using advanced imaging technology. The focus is on the treatment's impact on prostate cancer control and the side effects experienced by patients. Men diagnosed with prostate cancer who require prostate radical radiotherapy and meet specific criteria, such as having a tumor visible on an MRI scan, may qualify for this trial. As an unphased trial, this study offers patients the chance to contribute to pioneering research that could enhance future prostate cancer treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can continue taking androgen deprivation therapy (ADT) if it's part of your standard care.

What prior data suggests that this radiotherapy protocol is safe for prostate cancer treatment?

Research has shown that prostate cancer treatment with radical radiotherapy is generally safe and well-tolerated, even at varying dose levels. Studies have found that higher daily doses are both safe and effective. Notably, a large study discovered that a shorter course of radiation with standard doses is as effective as longer treatments.

Another study highlighted that increasing the radiation dose was well-tolerated, with only a small percentage of patients experiencing serious side effects. Specifically, only 1% to 2.3% of patients had severe long-term issues with their digestive or urinary systems.

Overall, these findings suggest that the treatment method used in this trial is safe, based on previous research.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using tailored radiotherapy doses for prostate cancer, which could lead to more personalized treatments. Unlike the standard uniform dose approach, the "De-escalated dose" arm targets the benign prostate tissue with a lower dose while focusing a higher dose specifically on the tumor mass, potentially reducing side effects and sparing healthy tissue. The "Uniform dose" arm serves as a comparison to evaluate the effectiveness of this targeted strategy. This trial aims to find out if these innovative dosing methods can maintain treatment efficacy while minimizing harm to surrounding healthy tissue, offering new hope for improved cancer care.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare two radiotherapy approaches for prostate cancer. Research has shown that radiotherapy can effectively treat prostate cancer. In this trial, one group will receive a de-escalated dose; past data suggested that the chances of the cancer not returning after 2 and 3 years were 58% and 46%, respectively. The other group will receive a uniform dose throughout treatment, which has shown benefits in controlling the disease over time. Both methods aim to manage prostate cancer effectively, balancing treatment effects with possible side effects.16789

Who Is on the Research Team?

AT

Alison Tree

Principal Investigator

Royal Marsden Hospital, Institute of Cancer Research

Are You a Good Fit for This Trial?

This trial is for men with intermediate-risk, localized prostate cancer confirmed by biopsy and MRI. Eligible participants have a Gleason score of 3+3, 3+4, or 4+3; PSA under 20 ng/ml if on hormone therapy; tumors smaller than 2.5 cm; good general health (WHO status 0-2); and can give informed consent.

Inclusion Criteria

My MRI lesion is cancerous and confirmed by biopsy.
My prostate cancer has a Gleason score of 3+3, 3+4, or 4+3.
I can continue my standard hormone therapy during the trial.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 fraction Stereotactic Body Radiotherapy (SBRT) using an MR Linac with daily adaptation

1 week
2 sessions (in-person)

Follow-up

Participants are monitored for acute GU toxicity and other outcomes post-treatment

12 weeks
Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for late toxicity, PSA control, and patient-reported outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Prostate radical radiotherapy

Trial Overview

The study compares two ways of giving high-dose radiotherapy in just two sessions using an MR-Linac machine: one group gets the same dose throughout the tumor, while the other gets a lower dose to some areas. The main goal is to see which approach causes fewer urinary side effects.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: De-escalated doseExperimental Treatment1 Intervention
Group II: Uniform doseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Royal Marsden NHS Foundation Trust

Lead Sponsor

Trials
331
Recruited
10,150,000+

Elekta Limited

Industry Sponsor

Trials
13
Recruited
8,900+

MRL Consortium

Collaborator

Trials
1
Recruited
50+

Citations

De-Escalation of Therapy for Prostate Cancer

The 2- and 3-year biochemical progression-free survival rates were 58% and 46%, respectively. ... Another prospective phase II trial by Glickman ...

Impact of radiation therapy dose escalation on prostate cancer ...

RT BED escalation has resulted in significantly improved PCa FFBF at up to 10 years; but not with improvement in OS, DM, or CSM.

Study Details | NCT06638541 | Dose dE-eScalaTion IN ...

Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy. The primary endpoint is acute GU CTCAE v5 grade 2+ toxicity. It will also ...

Fifteen-Year Outcomes after Monitoring, Surgery, or ...

After median follow-up of 15 years, 45 patients (2.7%) had died of prostate cancer: 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the ...

Clinical outcomes of external beam radiotherapy in ...

Median dose was 79.2 Gy. The 5-year OS were 90%, 87% and 78% and FFBF were 94%, 100% and 81% for low-, intermediate ...

Long-term outcomes from dose-escalated image-guided ...

Dose-escalated (DE) radiotherapy in the setting of localized prostate cancer has been shown to improve biochemical disease-free survival (bDFS) in several ...

Dose-escalation in prostate cancer: Results of randomized ...

The data from prospective randomized studies were ultimately disappointing in that they failed to show an overall survival benefit from dose escalation. However ...

Study confirms safety and efficacy of higher-dose-per-day ...

A new large-scale study provides the strongest evidence yet that a shorter, standard-dose course of radiation treatment is just as effective ...

Long-Term Outcomes of Dose-Escalated Hypofractionated ...

This work reports the results of HFRT on biochemical control, overall survival, toxicity and quality of life in patients with localized PCa treated with a dose ...