Active — Not RecruitingPhase 3

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

Netherlands280 participantsStarted 2020-03-19

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Histologically proven initial diagnosis of adenocarcinoma of the Prostate.

Exclusion criteria

✕. Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases.
✕. 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.
✕. Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes.
✕. Bone relapse on PSMA-PET/CT with a maximum of 3 lesions.
✕. Combination of a, b, c with a maximum of 4 metastases.
✕. Age \> 18 years.
✕. Recent PSMA-PET/CT scan within 60 days prior to randomization.
✕. PSA \< 10 ng/ml.

What they're measuring

Metastases progression-free survival (MPFS)

Timeframe: 2.5 years after treatment

Trial details

NCT IDNCT04302454

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-21

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