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

Prostate Cancer Clinical Trial

— ADOPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04302454
• Other study ID #: RT2019-13
• Status: Recruiting
• Phase: Phase 3
• Start date: March 19, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: Jorinde Janssen, MD
• Phone: 0031503615172
• Email: adopt[@]rt.umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiotherapy
Radiotherapy

Drug:
• Leuprorelin
Hormonal therapy

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC (Location VUmc)	Amsterdam	Noord-Holland
Netherlands	Radiotherapiegroep	Arnhem	Gelderland
Netherlands	Haga Hospital	Den Haag	Zuid-Holland
Netherlands	Radiotherapiegroep	Deventer	Overijssel
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant
Netherlands	UMCG	Groningen
Netherlands	Radiotherapy Institute Friesland	Leeuwarden	Friesland
Netherlands	Leinden University Medical Center	Leiden	Zuid-Holland
Netherlands	Maastro Clinic	Maastricht	Limburg
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Netherlands	Verbeeten Institute	Tilburg
Netherlands	Isala	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastases progression-free survival (MPFS)	The primary aim of this project is to test the hypothesis that the addition of ADT to MDRT in well-selected PCa patients with oligo-metastatic disease (OM) prolongs the metastases progression-free survival (MPFS) compared to MDRT alone	2.5 years after treatment