Radiation Therapy for Prostate Cancer

LR
Overseen ByLindsay Rowe, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: AHS Cancer Control Alberta
Must be taking: Androgen suppression
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of radiation therapy for prostate cancer that hasn't spread to the lymph nodes. One group will receive radiation targeted only at the prostate (Prostate Only Radiation Therapy, PORT), while the other will include the whole pelvis (Prostate + Whole Pelvis Radiation Therapy, P-WPRT). The goal is to determine which method better controls the cancer. Men diagnosed with high-risk localized prostate cancer who haven't started treatment yet may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have started any therapy for prostate cancer before the trial imaging.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Prostate Only Radiation Therapy (PORT) and Prostate + Whole Pelvis Radiation Therapy (P-WPRT) are generally manageable for patients. Studies on P-WPRT indicate it can be administered safely, with only about 5% of patients experiencing serious urinary side effects, meaning most people do not face major bladder control issues.

PORT directs radiation at the prostate and nearby areas, while P-WPRT covers the entire pelvis, potentially treating cancer cells outside the prostate. Both treatments have been used in similar situations before, and no major safety issues have been identified.

Overall, these treatments are considered safe, with few serious side effects, allowing most people to receive these therapies without significant health problems.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Prostate Only Radiation Therapy (PORT) and Prostate + Whole Pelvis Radiation Therapy (P-WPRT) because they offer focused and comprehensive approaches to treating prostate cancer. Unlike standard treatments that might involve surgery or hormone therapy, PORT targets just the prostate and surrounding tissues, potentially reducing side effects and sparing healthy tissues. P-WPRT goes a step further by including radiation to the whole pelvis, which might improve outcomes for patients with cancer that has a higher risk of spreading. These precise techniques could provide more effective treatment options with fewer complications compared to more invasive traditional methods.

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

This trial will compare Prostate Only Radiation Therapy (PORT) with Prostate + Whole Pelvis Radiation Therapy (P-WPRT). Research has shown that adding whole pelvis radiation therapy (WPRT) to prostate-focused treatment might benefit some prostate cancer patients. One study found that WPRT improved survival rates for patients with very high-risk prostate cancer compared to treating only the prostate. Another study found that WPRT significantly reduced the chances of cancer returning or worsening. However, a different study found no improvement in overall survival with WPRT compared to just treating the prostate, though it also did not worsen outcomes. While WPRT might benefit some patients, it carries a higher risk of certain side effects.12678

Are You a Good Fit for This Trial?

This trial is for men with high-risk prostate cancer that hasn't spread to the lymph nodes. Participants must be suitable for PSMA imaging, which helps visualize prostate cancer before starting treatment.

Inclusion Criteria

I have high-risk prostate cancer without spread to lymph nodes or other parts.
I am 18 years old or older.
I can take care of myself but might not be able to do heavy physical work.
See 10 more

Exclusion Criteria

I haven't had cancer in the last 5 years, except for certain skin cancers.
Bilateral hip prostheses
Inability to complete the investigational imaging examinations due to other reasons
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

PSMA imaging is used to visualize prostate cancer prior to starting the trial

1 week

Treatment

Participants receive radiation therapy targeted to the prostate and nearby tissues, with or without whole pelvis radiation therapy, along with hormone therapy

8-12 weeks

Follow-up

Participants are monitored for safety, effectiveness, and various outcomes such as toxicity and survival rates

5 years

Extended Follow-up

Long-term monitoring for outcomes such as biochemical failure free survival and distant metastases-free survival

5 additional years

What Are the Treatments Tested in This Trial?

Interventions

  • Prostate Only Radiation Therapy (PORT)
  • Prostate + Whole Pelvis Radiation Therapy (P-WPRT)

Trial Overview

The study is testing two types of radiation therapy: one targeting only the prostate (PORT) and another including the whole pelvis area (P-WPRT). Patients will be randomly assigned to either approach.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Prostate + Whole Pelvis Radiation Therapy (P-WPRT)Experimental Treatment1 Intervention
Group II: Prostate Only Radiation Therapy (PORT)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials
188
Recruited
26,900+

Cross Cancer Institute

Collaborator

Trials
62
Recruited
19,200+

Citations

Long-term outcomes of whole-pelvis radiation therapy ...

This study investigated the outcomes of whole-pelvis radiation therapy (WPRT) using volumetric modulated arc therapy (VMAT) for high-risk prostate cancer.

Examining the role of elective pelvic radiotherapy in ...

Conclusion. This retrospective analysis suggests that WPRT may offer significant survival benefits over PORT in patients with VHR prostate cancer, particularly ...

Prophylactic Whole-Pelvic RT Does Not Improve OS in ...

The 10-year OS rate, the study's primary endpoint, was 68%. No improvement was observed with WPRT compared to PORT (hazard ratio [HR], 1.01; 95% ...

Ten‐year outcomes of whole‐pelvic intensity‐modulated ...

Biochemical relapse‐free, overall, and prostate cancer‐specific survival rates at 10 years were 59.8%, 79.6%, and 86.3%, respectively. Loco‐ ...

Efficacy and Toxicity of Whole Pelvic Radiotherapy Versus ...

Conclusions: Meta-analysis demonstrates that WPRT can significantly improve BFFS and PFS for localized prostate cancer than PORT, but the increased risk of G2+ ...

Ten‐year outcomes of whole‐pelvic intensity‐modulated ...

Whole pelvic simultaneously integrated boost (WP SIB) IMRT can be delivered safely to patients with pelvic node-positive prostate cancer.

Dose-Effect Relations in the POP-RT Randomized Phase 3 ...

Conclusions. During long-term follow-up, whole pelvic radiation therapy resulted in low (∼5%) and similar grade 3 cumulative urinary toxicity as ...

Survival Outcomes of Whole-Pelvic Versus Prostate-Only ...

The purpose of our study was to evaluate the survival benefit of adding WPRT versus PO-RT for high-risk, node-negative prostate cancer, using the National ...