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

Phase 1

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

• Registration Number: EUCTR2019-003177-26-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-26
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 280

Inclusion Criteria

1.Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
2.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 > 0.1ng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).
3.Maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases.
a.Nodal relapse (N1) 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 (M1) 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.
4. Age > 18 years.
5.PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
6.PSA < 10 ng/ml.
7.In case of chronic use of finasteride the PSA value should be < 5 ng/ml
8.WHO performance state 0-2.
9.Signed informed consent prior to registration/randomization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1.Visceral metastases.
2.PSA = 10 ng/ml.
3.PSA-doubling time < 3 months.
4.ADT or chemotherapy for recurrent PCa.
5.Testosterone < 1.7 nmol/l
6.Painful metastases needed pain medication
7.Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.
8.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