Comparison of targeted radiotherapy with and without short-term hormonal treatment (6 months)

Phase 1

• Conditions: Patients with biochemical recurrence after primary treatment of prostatecancer presenting with =<4 metastases; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-511252-41-00
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-04
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 280

Inclusion Criteria

Histologically proven initial diagnosis of adenocarcinoma of the Prostate., Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA > O.lng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect)., Maximum 4 lesions (bone + lymph nodes) in total, without evidence of viscerai metastases. a. Nodal relapse (NI) in the pelvis on PSMA-PET scan with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. b. Nodal relapse (Ml) on PSMA-PET scan above the aortic bifurcation with a maximum of 3 positive lymph nodes. c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions., Age > 18 years., PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization., PSA < 10 ng/ml., In case of chronic use of finasteride the PSA value should be < 5 ng/ml., WHO performance state 0-2., DSigned informed consent prior to registration/randomization.

Exclusion Criteria

Visceral metastases., PSA => 10 ng/ml., PSA-doubling time < 3 months., ADT or chemotherapy for recurrent PCa., Testosterone < 1.7 nmol/l., Painful metastases needed pain medication., Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers., Inability to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified