Intense Radiotherapy for Prostate Cancer

Not currently recruiting at 12 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Must be taking: LHRH agonists

Disqualifiers: Other malignancies, Small-cell carcinoma, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks for hypofractionated, 7-8 weeks for conventional

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a shorter, more intense course of radiation is as safe and effective as the traditional longer treatment for high-risk prostate cancer. Participants will receive either the standard radiation (Conventional Radiation Therapy) over 7-8 weeks or a higher dose (Hypofractionation Radiation Therapy) over 5 weeks. The trial is suitable for men recently diagnosed with high-risk prostate cancer, who have specific clinical features such as advanced tumor stage or high PSA levels, and no spread to other parts of the body. Researchers will examine side effects, cancer progression, and overall quality of life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not have received any cytotoxic anticancer therapy for prostate cancer before joining the trial.

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

Research has shown that hypofractionated radiation therapy (HFRT), which delivers higher doses of radiation each day over a shorter period, is generally well-tolerated by patients. In a study involving over 9,000 men, researchers found no significant difference in cancer control or side effects between HFRT and the usual method. Another analysis revealed that patients receiving HFRT experienced similar cancer control and side effects as those undergoing traditional treatment.

Furthermore, a study on a more intense form of HFRT reported no severe side effects, indicating it is a safe option. This suggests the treatment could be as effective and safe as conventional radiation therapy, with the added benefit of a shorter treatment duration. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about hypofractionation radiation therapy for prostate cancer because it offers a quicker, more intense treatment option compared to conventional radiation therapy. Unlike standard treatments that require multiple sessions over several weeks, hypofractionation delivers higher doses of radiation in fewer sessions, potentially reducing the treatment time significantly. This approach could improve convenience for patients and possibly enhance the effectiveness of the therapy by delivering a more concentrated dose to the cancer cells.

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

This trial will compare two types of radiation therapy for prostate cancer: hypofractionated radiation therapy and conventional radiation therapy. Research has shown that hypofractionated radiation therapy, which participants in this trial may receive, shortens treatment time and can be as effective as traditional methods. Studies indicate that this approach maintains similar survival rates, with 98% of patients surviving at least five years without cancer progression. It effectively targets aggressive cancer cells while protecting healthy ones. Long-term evidence confirms that this shorter therapy is safe and does not increase side effects, making hypofractionation a promising option for efficiently treating high-risk prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Dr. Tamim Niazi, MDCM

Principal Investigator

Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for men with high-risk prostate cancer, defined as T3 or T4 stage, Gleason Score over 8, or PSA levels above 20. They must have no metastases on scans and a good performance status (able to carry out daily activities). Prior hormonal therapy is allowed if started within 28 days before the trial.

Inclusion Criteria

Hemoglobin > 100 g/L

My prostate cancer is high risk with a high Gleason score or PSA level.

I started androgen suppression therapy for my cancer less than 28 days ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either hypofractionated or conventional radiotherapy along with androgen deprivation therapy

5 weeks for hypofractionated, 7-8 weeks for conventional

Hormonal Therapy

Participants receive 28 months of androgen deprivation therapy (LHRH agonist)

28 months

Follow-up

Participants are monitored for acute and delayed toxicity, biochemical failure, and survival outcomes

6-8 years

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Radiation Therapy
• Hypofractionation Radiation Therapy

Trial Overview

The study tests whether a shorter, higher-dose radiation treatment (68 Gy in 25 fractions) can be as safe and effective as the standard longer course (76 Gy in 38 fractions) for prostate cancer. Both groups will also receive hormone therapy and are monitored for side effects and cancer control.

How Is the Trial Designed?

Group I: Hypofractionation Experimental Treatment 1 Intervention

One phase technique (IMRT or 3D-CRT): radiotherapy to the prostate + pelvic lymphnodes

Group II: Conventional Experimental Treatment 1 Intervention

two-phase technique (IMRT or 3D-CRT): 1) whole pelvis including the prostate and regional lymph nodes; 2) boost to the prostate

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+

Published Research Related to This Trial

Hypofractionated radiotherapy for prostate cancer, which delivers larger doses in fewer sessions, has shown improved biochemical control of the disease, supported by multiple clinical trials.

Advanced radiation techniques like 3D conformal radiotherapy and intensity modulated radiation therapy enable higher doses to the prostate while protecting surrounding healthy tissues, making hypofractionation a safer and more effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. Spyropoulou, D., Kardamakis, D.[2021]

In a pilot study involving 24 patients with low- to intermediate-risk prostate cancer, highly hypofractionated intensity modulated radiation therapy (IMRT) delivered 54 Gy in 15 fractions over 3 weeks resulted in high survival rates: 91.7% biochemical relapse-free survival and 95.8% overall survival at 5 years.

The treatment was well-tolerated, with no severe late gastrointestinal or grade ≥3 genitourinary toxicities observed, suggesting that this approach may be a safe and effective alternative to traditional radiation therapy methods.

NCBI (Pubmed)

pubmed.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. Nakamura, K., Ikeda, I., Inokuchi, H., et al.[2023]

In a study involving 200 patients with early-stage prostate cancer, extreme hypofractionated proton therapy (36.25 GyE in five fractions) demonstrated feasibility with a low rate of acute toxicity, where no patients experienced severe (G3) side effects.

After a median follow-up of 36 months, the treatment showed promising effectiveness, with no local recurrences of cancer and a low PSA relapse rate of 1.08% in low-risk and 6.5% in intermediate-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extreme hypofractionated proton radiotherapy for prostate cancer using pencil beam scanning: Dosimetry, acute toxicity and preliminary results. Kubeš, J., Vondráček, V., Andrlik, M., et al.[2020]

In a phase 3 trial involving 804 patients with localized prostate cancer, hypofractionated radiotherapy showed a 5-year relapse-free survival rate of 80.5%, which was not significantly better than the 77.1% rate for conventionally fractionated radiotherapy, indicating no superiority in treatment outcomes.

Both treatment regimens were found to be safe, with no treatment-related deaths reported, suggesting that while hypofractionation is not superior, it does not increase the risk of severe adverse effects compared to conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Incrocci, L., Wortel, RC., Alemayehu, WG., et al.[2022]

Recent evidence suggests that hypofractionated radiotherapy for prostate cancer is both safe and effective, particularly with a recommended regimen of 60 Gy in 20 fractions, which showed no significant increase in late toxicity.

While moderate hypofractionation has demonstrated positive 5-year outcomes in large trials, further research is needed for extreme hypofractionation techniques, and their use should currently be restricted to clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionation for prostate cancer: an update. Tiberi, D., Vavassis, P., Nguyen, D., et al.[2019]

In a study of 124 patients with high-risk prostate cancer, hypofractionated radiotherapy using simultaneous integrated boost-intensity modulated radiation therapy (SIB-IMRT) showed a low incidence of severe acute toxicity, with only 1.6% of patients experiencing grade 3 or higher side effects.

The treatment resulted in a promising five-year biochemical relapse-free survival rate of 86.5%, indicating its efficacy in preventing cancer recurrence after radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Postoperative IMRT in Prostate Carcinoma: A Phase I/II Study. Macchia, G., Siepe, G., Capocaccia, I., et al.[2021]

Moderate hypofractionated radiotherapy for prostate cancer is associated with a 6.3% increase in acute grade ≥ 2 gastrointestinal toxicity compared to standard fractionation, indicating a need for careful monitoring and management of these symptoms.

There was no significant increase in acute genitourinary toxicity or late toxicity levels between moderate hypofractionation and standard fractionation, suggesting that while acute GI symptoms may be more common, overall safety profiles for late effects are similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. Sinzabakira, F., Brand, V., Heemsbergen, WD., et al.[2023]

In a study involving 457 men with localized prostate cancer, hypofractionated high-dose radiotherapy (60 Gy and 57 Gy) was found to be as well tolerated as conventional radiotherapy (74 Gy) over a median follow-up of 50.5 months, with low rates of grade 2 or worse bowel and bladder toxicities.

The rates of bowel toxicity were 4.3% for the conventional group, 3.6% for the 60 Gy group, and 1.4% for the 57 Gy group, indicating that hypofractionated treatment may not increase the risk of side effects compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Dearnaley, D., Syndikus, I., Sumo, G., et al.[2023]

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