Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Dutch Cancer Society
• Treatments: Androgens; Leuprolide

Criteria

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.

1. Nodal relapse (N1) in the pelvis on PSMA-PET/CT with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.

2. Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes.

3. Bone relapse on PSMA-PET/CT with a maximum of 3 lesions.

4. Combination of a, b, c with a maximum of 4 metastases.

4. Age > 18 years.

5. Recent PSMA-PET/CT scan 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 unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.