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

University Medical Center Groningen (UMCG)

Status and phase: Active, not recruiting; Phase 3

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy; Drug: Leuprorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT04302454

RT2019-13

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Radiotherapy without hormonal therapy

Active Comparator group

Description:

Metastase-directed radiotherapy without the addition of hormonal therapy

Treatment:

Radiation: Radiotherapy

Radiotherapy combined with hormonal therapy

Experimental group

Description:

Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)

Treatment:

Drug: Leuprorelin

Radiation: Radiotherapy