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

Phase 3

Not yet recruiting

• Conditions: Patients with biochemical recurrence after primary treatment of prostate cancer presenting with =<4 metastases

• Registration Number: 2024-511252-41-00
• Lead Sponsor: Universitair Medisch Centrum Groningen

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Male
• Target Recruitment: 280

Inclusion Criteria

Histologically proven initial diagnosis of adenocarcinoma of the Prostate.

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 > O.lng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).

Maximum 4 lesions (bone + lymph nodes) in total, without evidence of viscerai metastases. a. Nodal relapse (NI) 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 (Ml) 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.

Age > 18 years.

PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.

PSA < 10 ng/ml.

In case of chronic use of finasteride the PSA value should be < 5 ng/ml.

WHO performance state 0-2.

DSigned informed consent prior to registration/randomization.

Exclusion Criteria

Visceral metastases.

PSA => 10 ng/ml.

PSA-doubling time < 3 months.

ADT or chemotherapy for recurrent PCa.

Testosterone < 1.7 nmol/l.

Painful metastases needed pain medication.

Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.

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

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the 2-year metastases progression free survival		The primary endpoint is the 2-year metastases progression free survival

Secondary Outcome Measures

Name	Time	Method
3 years PSA progression.		3 years PSA progression.
Start of 2nd line treatment.		Start of 2nd line treatment.
Start 2nd MDRT treatment for new (progressive) oligometastases.		Start 2nd MDRT treatment for new (progressive) oligometastases.
Acute and late toxicity (late toxicity up to 3 years).		Acute and late toxicity (late toxicity up to 3 years).
Clinical progression-free survival.		Clinical progression-free survival.
Quality of life.		Quality of life.
Progression pattern.		Progression pattern.
Time to start of palliative ADT.		Time to start of palliative ADT.
Time to castration-resistance.		Time to castration-resistance.
Disease-specific and overall survival.		Disease-specific and overall survival.
Sensitivity of the imaging modality (PSMA-PET/CT or PSMA-PET/MRI) for patients receiving MDRT.		Sensitivity of the imaging modality (PSMA-PET/CT or PSMA-PET/MRI) for patients receiving MDRT.
Predictive biomarkers.		Predictive biomarkers.

Trial Locations

Locations (10)

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Stichting Dr. Bernard Verbeeten Instituut; 🇳🇱 Tilburg, Netherlands

Radboud universitair medisch centrum / RADBOUDUMC; 🇳🇱 Nijmen, Netherlands

Maastro; 🇳🇱 Maastricht, Netherlands

Academic Medical Center At The University Of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Leids Universitair Medisch Centrum (LUMC); 🇳🇱 Leiden, Netherlands

Haga Hospital; 🇳🇱 's-Gravenhage, Netherlands

Catharina Ziekenhuis Stichting; 🇳🇱 Eindhoven, Netherlands

Radiotherapiegroep; 🇳🇱 Arnhem, Netherlands

Isala Klinieken Stichting; 🇳🇱 Zwolle, Netherlands

Universitair Medisch Centrum Groningen

🇳🇱Groningen, Netherlands

Shafak Aluwini

Site contact

+313611196

s.al-uwini@umcg.nl