Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy

Phase 3

Recruiting

• Conditions: prostaat kanker; hormone; radiotherapy

• Registration Number: NL-OMON52631
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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 or 3 consequent rises in PSA level (after exclusion of possible bounce
effect).
3. Minimal 1 lesion and 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 (M1a) 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.
d. Combination of a, b, c with a maximum of 4 metastases.
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.

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 (> level 1 pain medication) .
7. Invasive active cancers other than superficial non-melanoma skin cancers.
8. Inability or unwillngness to understand the information on trial-related
topics, to give informed consent or to fill out QoL questionnaires.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary goal of this project is to test the hypothesis that the addition of<br /><br>ADT to MDRT in well-chosen PCa patients with oligo-metastatic disease (OM)<br /><br>prolongs metastasis progression-free survival (MPFS) compared to radiotherapy<br /><br>alone.</p><br>