134 Participants Needed

Short vs Standard Duration Radiotherapy for Prostate Cancer

SC
PY
Overseen ByPragya Yadav, Ph.D.
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Weill Medical College of Cornell University
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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The investigators are also interested in looking at time to progression and the quality of life (health scores).

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.

What data supports the effectiveness of the treatment 20 days Radiation therapy, 5 days Radiation Therapy for prostate cancer?

Research indicates that the overall length of radiation treatment time does not significantly affect the clinical outcome for prostate cancer patients, suggesting that shorter treatment durations may be as effective as longer ones.12345

Is short or standard duration radiotherapy for prostate cancer safe?

The research does not provide specific safety data for short or standard duration radiotherapy for prostate cancer, but it mentions potential adverse effects of androgen deprivation therapy (ADT) used with radiotherapy, such as cardiovascular harm, neurocognitive and psychiatric events, and metabolic changes.13678

How does the short vs standard duration radiotherapy treatment for prostate cancer differ from other treatments?

This treatment is unique because it compares a shorter, 5-day radiotherapy schedule to the traditional, longer 20-day schedule, potentially offering similar outcomes with fewer sessions. This approach, known as hypofractionation, delivers higher doses per session over a shorter period, which may be more convenient for patients.1491011

Research Team

EW

Emily Weg, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

I am a man over 18 with prostate cancer confirmed by biopsy after surgery, and I have detectable PSA levels.
My scans show no cancer spread far from the original site, except possibly in pelvic lymph nodes.
I can undergo MRI-guided radiotherapy.
See 3 more

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • 20 days Radiation therapy
  • 5 days Radiation Therapy
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Group I: ARM 1 - 2 weeksActive Control1 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 weeksActive Control1 Intervention
Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.

Find a Clinic Near You

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+

Findings from Research

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

References

Picking the optimal duration of hormonal therapy in men with high-risk and locally advanced prostate cancer treated with radiotherapy. [2013]
A randomized trial (Irish clinical oncology research group 97-01) comparing short versus protracted neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. [2018]
Twice- vs. thrice-weekly moderate hypofractionated radiotherapy for prostate cancer: does overall treatment time matter? [2020]
Carcinoma of the prostate stage B and C: lack of influence of duration of radiotherapy on tumor control and treatment morbidity. [2019]
Prolongation of total treatment time because of infrequently missed days of treatment is not associated with inferior biochemical outcome after dose-escalated radiation therapy for prostate cancer. [2011]
Optimizing androgen deprivation therapy with radiation therapy for aggressive localized and locally advanced prostate cancer. [2022]
High-dose radiotherapy with or without androgen deprivation therapy for intermediate-risk prostate cancer: cancer control and toxicity outcomes. [2012]
Dose-escalated radiation therapy with and without short-course androgen deprivation for intermediate-risk prostate cancer. [2014]
[Role of hypofractionated radiotherapy in the treatment of prostate cancer: a review]. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Prognostic factors in prostate cancer. Analysis of 874 patients treated with radiation therapy. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. [2022]