Radiotherapy for prostate cancer recurrence after surgery

Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

This study is testing if a new type of focused radiation treatment can help men whose prostate cancer has come back after surgery feel better compared to standard radiation therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 284 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Jules Bordet Institute (Academic / other)
• Locations: 13 sites (Aalst and 12 other locations)
• Trial ID: NCT06523634 on ClinicalTrials.gov

What this trial studies

This clinical trial compares salvage stereotactic body radiotherapy (SBRT) with standard of care (SOC) regimens for patients experiencing biochemical recurrence of prostate cancer following radical prostatectomy. It is a multicentric randomized study where participants are assigned to either receive SBRT in five fractions or conventional radiotherapy in a normofractionated or mildly hypofractionated schedule. The goal is to evaluate the effectiveness of SBRT in managing persistent detectable PSA levels or biochemical progression in these patients.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with localized prostate adenocarcinoma who have undergone radical prostatectomy and have detectable PSA levels post-surgery.

Not a fit: Patients with advanced disease characteristics, such as distant metastases or significant surgical margins, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with recurrent prostate cancer after surgery.

How similar studies have performed: Other studies have shown promising results with SBRT in similar contexts, indicating potential for success in this approach.

Eligibility criteria

INCLUSION CRITERIA

1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \>0.1 ng/mL , or three consecutive PSA rises)
3. WHO PS 0-1
4. Age ≥18 years
5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry
6. Ability to understand and answer the EPIC-26 form in one of the languages available

EXCLUSION CRITERIA

1. Patients with a pT4 tumor at prostatectomy
2. Patients with previously pathologically confirmed N1
3. Patients with macroscopically involved margin at surgery (R2)
4. Patients with a history of distant metastases
5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \>1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.
6. Latest PSA \> 2ng/ml
7. Patients with a IPSS \>20
8. Gleason 10 tumor
9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
10. Prior pelvic radiotherapy
11. Prior hormonal therapy started more than 6 weeks before randomization
12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.

Where this trial is running

Aalst and 12 other locations

• AZorg — Aalst, Belgium (Recruiting)
• Ziekenhuis Aan de Stroom (ZAS) — Antwerp, Belgium (Recruiting)
• AZ Sint Jan — Bruges, Belgium (Recruiting)
• Jules Bordet Institute, H.U.B — Brussels, Belgium (Recruiting)
• Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan — Genk, Belgium (Recruiting)
• UZ Gent — Ghent, Belgium (Recruiting)
• Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
• AZ Groeninge — Kortrijk, Belgium (Recruiting)
• CHU HELORA - Hôpital de La Louvière - site Jolimont — La Louvière, Belgium (Recruiting)
• UZ Leuven — Leuven, Belgium (Recruiting)
• AZ Sint-Maarten — Mechelen, Belgium (Recruiting)
• CHU UCL Namur - Site Elisabeth — Namur, Belgium (Recruiting)
• Cliniques universitaires Saint-Luc (UCLouvain) — Woluwe-Saint-Lambert, Belgium (Recruiting)

Study contacts

• Study coordinator: Robbe Van den Begin, MD, PhD

Conditions Prostate Cancer