Radiotherapy Schedules for Recurrent Prostate Cancer

(HYP-OP-RT Trial)

Not yet recruiting at 3 trial locations

Overseen By Josée Allard, BInf

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must be taking: Hormone therapy

Disqualifiers: Prior pelvic radiotherapy, Metastatic disease, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a shorter radiotherapy schedule is as safe and effective as the standard treatment for prostate cancer that has returned after surgery. It compares two radiotherapy schedules: one lasting about five weeks and another lasting about four weeks. Both groups may also receive hormone therapy (Androgen Deprivation Therapy, or ADT) to help control the cancer. The trial evaluates side effects, cancer control, and quality of life. Men who have undergone prostate surgery, have detectable PSA levels, and are in good health are suitable candidates for this study. As an unphased trial, this study allows patients to contribute to important research that may improve future treatment options.

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

A previous study found that a shorter, more intense radiation schedule, known as hypofractionated radiotherapy, was safe and effective for prostate cancer patients. It had moderate side effects, similar to the usual radiation schedule, and provided good cancer control. Research has shown low rates of severe side effects even over the long term.

For standard radiotherapy treatment, studies suggest it might be the only option to cure cancer if it recurs, and it appears more effective when administered early. Both treatment options in this trial aim to control cancer and manage side effects like urinary or bowel problems.

Overall, past studies consider both the shorter and standard radiation schedules safe with manageable side effects. This trial will further explore whether the shorter schedule is as safe as the standard one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the different radiotherapy schedules for recurrent prostate cancer because they offer potential improvements in treatment efficiency and patient convenience. The hypofractionated post-operative salvage radiotherapy (Arm B) delivers higher doses in fewer sessions compared to the standard fractionation approach (Arm A). This means patients could complete their treatment in less time, which can lead to less disruption in their daily lives and potentially fewer side effects. By exploring these differing schedules, researchers hope to find the optimal balance of effectiveness and patient quality of life.

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

This trial will compare two radiotherapy schedules for recurrent prostate cancer. Studies have shown that shorter courses of radiotherapy, like the hypofractionated schedule tested in this trial, are as safe and effective as traditional longer treatments, such as the standard fractionation schedule also under study. Research indicates that these shorter treatments control cancer recurrence effectively and have moderate side effects. For the standard longer radiotherapy, evidence supports its effectiveness in reducing cancer recurrence after surgery. Both methods show promising 5-year survival rates, demonstrating similar success in controlling cancer. Both treatment arms in this trial may also include hormone therapy to enhance results. ^{1 3 5 6 7}

Who Is on the Research Team?

Eric Vigneault, MD, MSc

Principal Investigator

CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

Inclusion Criteria

My kidney, liver, and blood tests are within normal limits.

I have had my prostate removed and now have a PSA level of 0.2 ng/mL or higher.

I have been diagnosed with prostate adenocarcinoma.

Exclusion Criteria

I have active inflammatory bowel disease or a gut condition that increases radiation risk.

Uncontrolled comorbidities affecting study participation

I have not had systemic therapy for recurrent prostate cancer, except recent ADT.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive post-operative salvage radiotherapy. Arm A: 25 sessions over 5 weeks; Arm B: 20 sessions over 4 weeks. Both groups may receive hormone therapy (ADT) for 6-24 months.

4-5 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life. This includes assessments of PSA levels, survival, and quality of life questionnaires.

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Androgen Deprivation Therapy (ADT)
• Hypofractionated Post-Operative Salvage Radiotherapy
• Standard Fractionation Post-Operative Salvage Radiotherapy

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 2 Interventions

Prostate bed 52.5 Gy / 20 Pelvis 43 Gy / 20 (+/-52 Gy/20) ADT

Group II: Arm A Active Control 2 Interventions

Prostate bed 62.5 Gy / 25 Pelvis 45 Gy / 25 (+/-55 Gy/25) ADT

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

TerSera Therapeutics LLC

Industry Sponsor

Trials

11

Recruited

1,300+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39766126/

Evidences on the Use of Hypofractionation in ...

Hypofractionated treatment has been shown to be safe, effective, with moderate toxicity and not inferior to conventional RT, with good biochemical control ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1558767324000739

10-yr Results of Moderately Hypofractionated ...

Our study provides long term data that a shortened course of postoperative RT is as safe and effective as a long course of conventionally fractionated RT.

3.

mdpi.com

mdpi.com/2072-6694/16/24/4227

Evidences on the Use of Hypofractionation in ...

Hypofractionated treatment has been shown to be safe, effective, with moderate toxicity and not inferior to conventional RT, with good biochemical control ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8532339/

Salvage hypofractionated accelerated versus standard ... - PMC

This study is designed to demonstrate whether hypofractionated radiotherapy is beneficial in terms of biochemical control and toxicity compared with standard ...

5.

academic.oup.com

academic.oup.com/jrr/article/67/2/161/8496201

Salvage stereotactic body radiotherapy for post-prostatectomy ...

Across the available literature, moderate HFRT using 2.5–3.0 Gy per fraction over 15–28 fractions has shown favorable tumor control with ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0167814026003889

Safety and efficacy of moderately hypofractionated ...

The present study prospectively reported the safety and efficacy of moderately hypofractionated RT consisting of 18 fractions for prostate cancer following ...

7.

boa.unimib.it

boa.unimib.it/retrieve/ddf065f4-9d0a-4e92-840b-cb041ff4ff31/Castelluccia-2024-Clinical%20Genitourinary%20Cancer-VoR.pdf

10-yr Results of Moderately Hypofractionated ...

This retrospective study on postoperative hypofractionated RT for prostate cancer (110 patients, 103-month follow-up) reveals low rates of severe toxicities.