Short vs Standard Duration Radiotherapy for Prostate Cancer

Overseen By Pragya Yadav, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pelvic radiotherapy, Inflammatory bowel disease, 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

Compensation: Varies

Number of Visits: 8

Duration: 2-4 weeks

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 has returned after surgery. It examines whether a shorter, intense two-week treatment causes different side effects compared to a longer, less intense four-week treatment. Researchers compare the side effects on urinary and bowel functions and overall quality of life. Men who have undergone prostate cancer surgery and have detectable PSA levels (a protein indicating prostate cancer) might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in prostate cancer therapy.

Do I need to stop my current medications for this trial?

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.

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

Research has shown that both the 5-day and 20-day radiation treatments for prostate cancer are generally safe for patients. The 5-day treatment matches the effectiveness and safety of longer, traditional treatments. This shorter approach is increasingly used without compromising patient safety.

For the 20-day treatment, evidence also supports its safety. This standard-dose radiation over a shorter period remains effective without raising safety concerns. However, some studies suggest a higher chance of urinary problems in the first two years after treatment.

Overall, both treatment options are well-tolerated, with no severe side effects reported in the studies. This suggests these therapies are manageable for most patients considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring different durations of radiotherapy for prostate cancer because these methods could make treatment more convenient and potentially just as effective. The two approaches being looked at are a short 5-day course and a standard 20-day course of radiation therapy. The 5-day treatment delivers a higher dose per session but fewer sessions overall, which means less time in treatment and possibly fewer side effects. This could be a game changer compared to the current standard of care, which typically involves about 6 to 8 weeks of radiotherapy. By finding out if shorter treatment durations are just as effective, patients might face less disruption to their lives while still achieving good outcomes.

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

This trial will compare two different durations of radiation therapy for prostate cancer. Research has shown that both shorter and standard lengths of radiation therapy effectively treat prostate cancer. Participants in one arm of this trial will receive ultra-hypofractionated radiation therapy over 5 days. Studies have found this approach provides excellent cancer control and is safe for some types of prostate cancer. Its popularity has increased due to its convenience and effectiveness. Participants in the other arm will receive the 20-day radiation therapy, which also delivers strong results, with high survival rates and a low chance of recurrence. Both treatments are well-tolerated and offer effective ways to manage prostate cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Emily Weg, M.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for men over 18 with prostate cancer that's come back after surgery. They need a detectable PSA level (unless they have node-positive disease), no distant metastatic disease, and must be able to undergo MRI-guided radiotherapy and fill out a quality of life questionnaire. Men with prior pelvic radiation, inflammatory bowel disease, or other serious cancers can't join.

Inclusion Criteria

My scans show no cancer spread far from the original site, except possibly in pelvic lymph nodes.

I can undergo MRI-guided radiotherapy.

I am mostly able to care for myself.

Exclusion Criteria

I have inflammatory bowel disease.

I have had radiation therapy to my pelvic area before.

I have had a narrowing of my bladder neck or urethra.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either hypofractionated radiotherapy over 4 weeks or ultra-hypofractionated radiotherapy over 2 weeks

2-4 weeks

5-20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Regular visits at 3, 6, 12, 24, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• 20 days Radiation therapy
• 5 days Radiation Therapy

Trial Overview The study compares two types of salvage radiotherapy for recurrent prostate cancer: one group receives treatment spread over 4 weeks (20 sessions) while the other gets it condensed into 2 weeks (5 sessions). The focus is on side effects related to urinary and bowel function, time until the cancer progresses again, and patient health scores.

How Is the Trial Designed?

Group I: ARM 1 - 2 weeks Active Control 1 Intervention

Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.

Group II: ARM 2 - 4 weeks Active Control 1 Intervention

Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Viewray Inc.

Industry Sponsor

Trials

13

Recruited

1,100+

Published Research Related to This Trial

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]

Citations

1. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Men who received the shortened treatment, called stereotactic body radiotherapy (SBRT), did not have a higher risk of cancer recurrence over the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7532562/

Long-term outcomes of moderately hypofractionated ... 5- and 10-year biochemical relapse free survival for 244 high risk patients were 63% and 42%, 5- and 10-year clinical failure free survival were 87% and 72%, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7528218/

Comparison of outcomes and toxicities among radiation ... SBRT had promising rates of BF, with shorter follow-up (5-year FFBF of >90% for low-risk patients). Similarly, BT (5-year FFBF for low-, intermediate-, and high ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1278321825000940

Moderate hypofractionated radiotherapy for localised ... Overall, 12-year estimated survival rate was similar at 68.7 % for conventional fractionation and 69.9 % for modest hypofractionation (HR: 1.01). The most ...

5. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2023/high-cure-rate,-low-toxicity-maintained-with-shortened-radiation-treatment-for-intermediate-risk-pro

High cure rate, low toxicity maintained with shortened ... “Standard radiation treatment is already highly effective and is very well tolerated in people with localized prostate cancer,” Prof. van As ...

6. uclahealth.org uclahealth.org/news/release/study-confirms-safety-and-efficacy-higher-dose-per-day

Study confirms safety and efficacy of higher-dose-per-day ... Patients who received higher dose-escalated MHFRT did not improve cancer control when compared to those receiving standard doses, with five-year ...

7. newsroom.ucla.edu newsroom.ucla.edu/releases/study-confirms-safety-and-efficacy-of-higher-dose-per-day-radiation-for-early-stage-prostate-cancer

Study confirms safety and efficacy of higher-dose-per-day ... A shorter, standard-dose course radiation treatment is just as effective as conventional radiotherapy for prostate cancer without compromising patient safety.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4961874/

Conventional versus hypofractionated high-dose intensity ... Prostate cancer might have high radiation-fraction sensitivity that would give a therapeutic advantage to hypofractionated treatment.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023001753

Long-Term Outcomes of a Prospective Study on Highly ... No grade ≥3 adverse events were observed, suggesting that highly hypofractionated IMRT is a safe treatment. Conventional fractionated radiation therapy at 1.8 ...