Actively Recruiting

Phase 3
Age: 18Years +
MALE
ID05352178

A New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

873

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether adding short-term androgen deprivation therapy (ADT) for either 1 month or 6 months, combined with an androgen receptor targeted therapy (ARTA), to metastasis-directed therapy (MDT) can significantly extend the time patients with oligorecurrent hormone sensitive prostate cancer remain free from widespread metastases or metastatic castration-resistant prostate cancer. This phase 3 clinical trial explores improving outcomes by combining systemic treatments with targeted therapies in men whose cancer has returned but remains hormone sensitive. The study compares three treatment groups: MDT alone, MDT plus 1 month of ADT (using drugs such as gosereline, leuproreline, or triptoreline), and MDT plus 6 months of ADT combined with the ARTA drug enzalutamide. MDT involves stereotactic body radiotherapy (SBRT) or surgery to target metastatic lesions. Participants receive these treatments according to their assigned group, with dosing schedules including monthly or quarterly injections of ADT drugs and daily oral enzalutamide during the 6-month period. Participants will be involved in the study for up to 10 years, with follow-up assessments up to 5 years for outcomes like poly-metastatic free survival, metastatic castration-resistant prostate cancer free survival, biochemical and clinical progression-free survival, quality of life, and treatment toxicity. Researchers will monitor these outcomes alongside overall and cancer-specific survival to evaluate the long-term benefits and safety of adding systemic therapy to MDT in this patient group.

CONDITIONS

Brief Title

Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven initial diagnosis of prostate adenocarcinoma
  • Primary tumor previously treated and controlled
  • Biochemical recurrence with PSA >0.2 ng/ml following radical prostatectomy and/or high-dose radiotherapy
  • Oligorecurrent disease with a maximum of 5 extracranial metastases diagnosed on PSMA PET-CT or PET-MRI
  • Nodal disease included only with M1a-c disease and total lesions not exceeding 5
  • Serum testosterone level within normal range
  • WHO performance status 0-2
  • Age 18 years or older
  • No psychological, sociological, or geographical conditions affecting study compliance
  • Approval by multidisciplinary board meeting
  • Voluntary written informed consent obtained
  • Use of highly effective birth control methods during the trial period
Not Eligible

You will not qualify if you...

  • Any disorder compromising participant safety or study compliance
  • Prior or concurrent treatments jeopardizing safety or trial integrity
  • Participation in another interventional trial with investigational drugs or devices
  • Serum testosterone at castration level
  • PSA rise while on active hormonal treatment
  • Presence of more than 5 metastatic lesions (poly-metastatic disease)
  • Active malignancies other than prostate cancer affecting study interpretation
  • Previous treatments or comorbidities preventing new stereotactic body radiotherapy
  • Contraindications to enzalutamide such as seizure risk or recent significant cardiovascular events
  • Inability to understand treatment protocol or provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Metastasis-directed therapy

Duration - Up to 1 month

Participants receive treatment targeting metastatic lesions using stereotactic body radiotherapy (SBRT) and/or surgery (metastasectomy).

1 to 2 visits depending on treatment type

Androgen deprivation therapy (ADT) and Androgen receptor targeted therapy (ARTA)

Duration - 1 month or 6 months depending on treatment arm

Participants in experimental arms receive short-term ADT for either 1 month or 6 months, with the 6-month group also receiving enzalutamide daily during this period.

Monthly visits corresponding to ADT administration

Follow-up

Duration - Up to 10 years after metastasis-directed therapy

Participants are monitored for poly-metastatic free survival, castration-refractory prostate cancer free survival, progression-free survival, toxicity, quality of life, and overall survival.

Regular visits as scheduled over several years for ongoing monitoring

Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Belgium

Actively Recruiting

Loading map...

Research Team

K

Kato Rans, MD

G

Gert De Meerleer, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With...

Prostate Cancer

Actively Recruiting

1 location

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Direc...

Metastatic Prostate Cancer

Actively Recruiting

1 location

18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Phase III Ac...

Prostate Cancer

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

SPARKLE: a new spark in treating oligorecurrent prostate cancer: adding systemic treatment to stereotactic body radiotherapy or metastasectomy: key to long-lasting event-free survival?

Kato Rans, Berghen Charlien, Ameye Filip...

https://pubmed.ncbi.nlm.nih.gov/36503429