Short vs Long Course Radiotherapy for Prostate Cancer

(CONSORT-PC Trial)

Overseen By Peter Chung, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must be taking: ADT, ARAT

Disqualifiers: Prior pelvic radiotherapy, Ulcerative colitis, Crohn's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different radiotherapy schedules for prostate cancer to compare their side effects. One group receives radiation every other day for two weeks, while the other receives it once a week for six weeks. The researchers aim to determine if the shorter, more frequent treatment is as safe as the longer, less frequent one. The trial seeks participants with metastatic prostate cancer who are already receiving or planning to receive certain treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in prostate cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that you can be on systemic treatment like ADT (androgen deprivation therapy) with or without ARAT (androgen receptor axis-targeted therapy), and previous chemotherapy is allowed if it was completed more than 6 weeks before joining the trial.

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

Research has shown that shorter courses of radiotherapy for prostate cancer are well-tolerated by patients. Studies indicate that this method is both safe and effective. For example, new research suggests that a shorter course of radiation is safe for men with high-risk prostate cancer and leads to positive outcomes. Another study found that targeted, short-course radiation therapy helps maintain urinary control and sexual function better than surgery. This evidence suggests that shorter radiotherapy schedules are generally manageable and safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for prostate cancer?

Researchers are excited about this trial because it explores two different approaches to delivering radiotherapy for prostate cancer, potentially offering more flexible treatment options. The investigational approach delivers the same radiation dose over a shorter period—just two weeks instead of the standard six weeks—by scheduling sessions every other day. This could make the treatment more convenient and less burdensome for patients. Additionally, by maintaining the same total radiation dose, this method aims to preserve effectiveness while improving the patient experience.

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

This trial will compare short and long courses of radiotherapy for prostate cancer. Research has shown that shorter courses of radiotherapy are effective. One study found that patients receiving fewer but higher doses of radiation achieved high cure rates with few side effects. Another study discovered that just five treatment sessions were as effective as 20 or more over several weeks. In this trial, participants in Arm 1 will receive a shorter course of radiation treatment (36 Gy in 6 fractions) delivered every other day over 2 weeks. Participants in Arm 2 will receive the standard course of radiation treatment (36 Gy in 6 fractions) delivered once a week over 6 weeks. Shorter treatments are becoming more common due to their effectiveness and convenience. Overall, shorter radiotherapy courses offer a promising option for prostate cancer patients. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Men aged 18+ with metastatic prostate cancer, either low or high volume, are eligible. They must be fit for daily activities (ECOG 0 or 1), planning to receive external beam radiation therapy (EBRT) while on hormone therapy +/- ARAT. Prior chemotherapy is okay if it was over six weeks ago. Men with active inflammatory bowel disease or conditions that rule out radiotherapy, especially prior pelvic radiation, can't join.

Inclusion Criteria

I am scheduled for external beam radiation therapy.

My cancer has spread to other parts of my body, including possibly my bones or organs.

My prostate cancer has spread and was confirmed by a biopsy.

Exclusion Criteria

I have a health condition that prevents me from receiving radiotherapy.

I have had radiation therapy to my pelvic area before.

My doctor confirms I have active ulcerative colitis or Crohn's Disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation treatment. Arm 1: every other day for 2 weeks; Arm 2: once a week for 6 weeks

2-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiotherapy

Trial Overview

This study compares two schedules of delivering radiation treatment for metastatic prostate cancer: one group will receive treatments every other day for two weeks and the other once weekly for six weeks. The goal is to see if side effects differ between these schedules.

How Is the Trial Designed?

Group I: Arm 2 - Standard Experimental Treatment 1 Intervention

Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.

Group II: Arm 1 - Investigational Experimental Treatment 1 Intervention

Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).

Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in United States as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Canada as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Japan as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in China as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Switzerland as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Combining androgen suppression therapy with external-beam radiation therapy has become the standard treatment for men with locally advanced prostate cancer, significantly improving outcomes such as disease control and survival rates.

Hormonal therapy should be started before radiation and continued throughout the treatment, with recent studies showing that shorter courses of hormone therapy (4 to 6 months) can be effective, challenging the previous belief that longer courses were always necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy combined with hormone therapy for prostate cancer. Lee, AK.[2007]

In patients with early-stage prostate cancer (stage A and B), external beam radiation therapy shows equivalent 10-year outcomes compared to radical prostatectomy, indicating its effectiveness as a treatment option.

For more advanced prostate cancer (stage C), external beam radiation has proven effective with long-term results from thousands of patients, establishing it as the standard treatment against which new therapies should be evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External beam radiation treatment for prostate cancer: still the gold standard. Hanks, GE.[2007]

In a study of 54 patients under 60 years old with early-stage prostate cancer, external beam radiation therapy showed similar rates of local and metastatic control compared to older patients (60-70 years old), indicating its efficacy in younger patients.

Patients with locally advanced node-negative prostate cancer had poorer outcomes in local control and survival compared to those with early-stage disease, suggesting that treatment strategies may need to be adjusted for better management of advanced cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy for prostatic cancer: patient selection and the impact of local control. Kaplan, ID., Cox, RS., Bagshaw, MA.[2019]

External beam radiotherapy (RT) has evolved significantly over the past 50 years, with modern techniques greatly improving its effectiveness in treating prostate cancer, thanks to advancements in computer and imaging technologies.

The review highlights the importance of predictive factors in determining the outcomes of external beam RT, whether used alone, in combination with androgen suppression, or as a postoperative treatment, emphasizing its role in contemporary patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External beam radiotherapy as curative treatment of prostate cancer. Pisansky, TM.[2013]

In a study of 173 patients with high-risk localized prostate cancer, long-term androgen deprivation therapy (ADT) for 36 months or more combined with external-beam radiotherapy (EBRT) significantly improved five-year progression-free survival rates (92.8%) compared to short-term ADT (72.9%).

Patients receiving short-term ADT experienced a higher incidence of cardiovascular toxicity (grade II or above) compared to those on long-term ADT, indicating that longer ADT may not only enhance survival but also have a more favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the duration of hormonal therapy following radiotherapy for localized prostate cancer. Okubo, M., Nakayama, H., Itonaga, T., et al.[2022]

In a Phase II trial involving 138 patients with localized prostate cancer, the combination of external-beam radiation therapy and low-dose-rate permanent brachytherapy showed an 8-year biochemical control rate of 82% to 79%, indicating durable effectiveness in managing the disease.

However, the study reported a significant late toxicity rate, with 15% of patients experiencing severe genitourinary or gastrointestinal side effects, and 42% reporting grade 3 impotence, suggesting a need for improved strategies to minimize damage to healthy tissues during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate. Lawton, CA., Yan, Y., Lee, WR., et al.[2018]

In a study of 7661 men with nonmetastatic prostate cancer who received radiotherapy, only 6.5% experienced complications within 30 days, indicating that short-term complications are relatively uncommon after this treatment.

Older age was linked to a higher risk of certain complications, but overall complication rates after radiotherapy were lower compared to those who underwent radical prostatectomy, suggesting that radiotherapy may be a safer option for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major 30-day complications after radical radiotherapy: a population-based analysis and comparison with surgery. Alibhai, SM., Leach, M., Warde, P.[2009]

External beam radiation therapy for localized prostate cancer shows a high disease-free survival rate of nearly 80% at 5 years and 53% at 10 years, particularly for cancer confined to the prostate.

The treatment is well tolerated with a low rate of severe side effects, making it a viable option compared to radical prostatectomy, especially considering the prognostic factors analyzed in the study of 431 patients over a median follow-up of 4 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy of localized prostate cancer. Landmann, C.[2006]

Management of high-risk prostate cancers remains debated due to the lack of randomized trials comparing surgery and radiotherapy, but long-term androgen deprivation therapy (at least 18 months) is recommended when using external beam radiotherapy.

Combining external beam radiotherapy with brachytherapy has shown improved biochemical control in trials, and while it hasn't impacted overall survival, large retrospective studies suggest it may enhance specific and overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of radiotherapy for high risk localized prostate cancers. Hennequin, C., Labidi, M., Quéro, L.[2021]

In a study of 120 high-risk prostate cancer patients, those treated with definitive external-beam radiotherapy (ExRT) had significantly better biochemical failure-free survival (BFFS) compared to those who underwent radical prostatectomy (RP), with BFFS of 97.8 months versus 34.4 months, respectively.

Despite the differences in BFFS, the rates of distant metastasis-free survival (DMFS), cancer-specific survival (CSS), and overall survival (OS) were similar between the two treatment groups, indicating that while ExRT may reduce the risk of biochemical failure, both treatments can achieve comparable long-term survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive external-beam radiotherapy versus radical prostatectomy in clinically localized high-risk prostate cancer: a retrospective study. Andic, F., Izol, V., Gokcay, S., et al.[2020]

The triple-course external beam irradiation technique for localized prostate cancer resulted in a high clinical local control rate of 96% and an 86% negative biopsy rate among treated patients, indicating effective treatment outcomes.

While 96% of patients experienced mild to moderate bladder and bowel reactions, only 2% had severe complications, suggesting that this treatment method is associated with minimal acute morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple course external beam radiotherapy for carcinoma of the prostate. El-Mahdi, AM., Turalba, CI., Schellhammer, PF., et al.[2019]

External beam radiation therapy is an effective treatment for organ-confined and early-stage prostate cancer, showing good biochemical and overall survival rates.

Advanced techniques like intensity-modulated and three-dimensional conformal radiotherapy provide better tumor control with fewer complications, making them preferable for intermediate- and high-risk patients compared to radical prostatectomy, although both treatments yield similar quality of life outcomes post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after external beam radiation therapy for T1-T2 localized prostate cancer. Lagerveld, BW., Laguna, MP., de la Rosette, JJ.[2022]

Hypofractionated radiotherapy, which delivers higher doses per session than conventional methods, may offer enhanced anti-tumor efficacy and a shorter treatment duration for prostate cancer, based on a systematic review of five randomized trials and thousands of patients.

Current evidence suggests that while hypofractionation could be a promising alternative to traditional radiotherapy, further results from ongoing randomized trials are needed before making changes to standard treatment practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of hypofractionated radiotherapy in the treatment of prostate cancer: a review]. Toledano, A., Beley, S., Bollet, M., et al.[2018]

In a study of 205 patients with local prostate cancer treated with megavoltage radiation, the local control rates were high, with 96% for stage A2, 94% for stage B, and 90% for stage C, indicating effective treatment across different cancer stages.

The overall survival rate was 71% and the disease-free survival rate was 60% over a median follow-up of 9.4 years, with only a low incidence of complications (0.5% requiring surgery), suggesting that radiation therapy is a safe and effective option for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer: results of external irradiation. Reddy, EK., Krishnan, L., Giri, S., et al.[2018]

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