Surgery vs Radiotherapy for Prostate Cancer
(PACE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best treatment option for prostate cancer by comparing surgery and various types of radiotherapy. It aims to determine which approach is more effective, has fewer side effects, and offers a better quality of life for patients. The trial includes men diagnosed with prostate cancer who may have different risk levels and specific treatment needs. Those recently diagnosed with prostate cancer and considering treatment options might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy (ADT) and are participating in PACE-A or PACE-B, you may need to stop, as prior ADT is an exclusion criterion for these groups.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that prostate SBRT, a type of targeted radiation therapy, is generally safe for treating prostate cancer. Studies indicate it has a good safety record, with many patients experiencing only mild side effects. For instance, one study found that 27% of men had urinary issues compared to 18% with standard radiation therapy, but these differences were not significant. Patients often handle SBRT well over long-term follow-ups.
Conventionally fractionated prostate radiotherapy is also well-tolerated. Evidence from multiple studies confirms its safety and effectiveness for localized prostate cancer. This treatment involves administering radiation in smaller doses over a longer period, which has shown good safety results in clinical trials.
Laparoscopic prostatectomy, a surgical option, is generally safe as well. Research shows it provides good cancer control and survival rates. Some patients may experience minor complications, but overall, it is a viable option for many.
Each treatment has its own benefits and risks, but they all have promising safety records based on current research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the different approaches being tested for prostate cancer because they offer potentially less invasive and more convenient alternatives to traditional treatments like surgery and conventional radiotherapy. One standout feature is the use of Stereotactic Body Radiotherapy (SBRT), which delivers high doses of radiation in just five sessions compared to the typical 20 to 39 sessions needed for conventional radiotherapy. This condensed schedule could mean less time in treatment and fewer side effects for patients. Additionally, the laparoscopic prostatectomy method being tested is minimally invasive, which might lead to faster recovery times and less post-operative discomfort compared to traditional open surgery. These innovative approaches aim to maintain or improve effectiveness while enhancing patient comfort and convenience.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
This trial will compare different treatment options for prostate cancer. Research has shown that laparoscopic prostatectomy, one of the surgical options in this trial, can effectively reduce prostate cancer deaths by 11.7%. In the PACE-A arm, participants will be randomized to receive either prostatectomy or Prostate SBRT. Traditional radiotherapy, which uses radiation to treat cancer, is as effective as other radiation methods, with ten-year studies showing similar results. In the PACE-B and PACE-C arms, participants will be randomized to receive either conventionally fractionated radiotherapy or Prostate SBRT. Prostate SBRT, a precise form of radiation therapy, is also a strong option. Specifically, five-year studies show it prevents cancer recurrence in 95.8% of cases. Overall, each treatment has evidence supporting its effectiveness for prostate cancer.25678
Who Is on the Research Team?
Alison Tree, MD
Principal Investigator
Royal Marsden NHS Foundation Trust, London, United Kingdom
Nicholas van As, MD
Principal Investigator
Royal Marsden NHS Foundation Trust, London, United Kingdom
Peter Ostler, MD
Principal Investigator
Mount Vernon Cancer Centre, United Kingdom
Are You a Good Fit for This Trial?
Men over 18 with prostate cancer that's not spread beyond the prostate (T1c-T2c, N0-X, M0-X) and a Gleason score ≤ 3+4. They must have had at least 10 biopsy cores taken within the last year and a half, PSA levels ≤ 20 ng/ml, and a prostate size ≤ 90 cc. Men who are very sick (WHO performance status >2), or whose cancer has spread further can't join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either prostatectomy, conventionally fractionated radiotherapy, or prostate SBRT based on risk group and treatment considerations
Follow-up
Participants are monitored for efficacy, toxicity, and quality of life outcomes
Extension/Long-term follow-up
Participants are monitored for disease-specific and overall survival, as well as progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Conventionally Fractionated Prostate Radiotherapy
- Laproscopic Prostatectomy
- Prostate SBRT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Royal Marsden NHS Foundation Trust
Lead Sponsor
The Institute of Cancer Research, Sutton, Surrey, UK
Collaborator