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

NCT04302454 | Active Not Recruiting Phase 3

• 1 other identifier: RT2019-13
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 13

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Oligometastasis; Stereotactic Body Radiation Therapy; Androgen Deprivation Therapy; Biochemical recurrence; PSMA PET/CT; Metastases-directed radiotherapy; Metastases progression-free survival

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Radiotherapy without hormonal therapy

ACTIVE COMPARATOR

Metastase-directed radiotherapy without the addition of hormonal therapy

Radiation: Radiotherapy

Radiotherapy combined with hormonal therapy

EXPERIMENTAL

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

Radiation: Radiotherapy; Drug: Leuprorelin

Interventions

Radiotherapy RADIATION

Radiotherapy

Also known as: MDRT, Metastase-directed radiotherapy, SBRT, Stereotactic body radiotherapy

Radiotherapy combined with hormonal therapy; Radiotherapy without hormonal therapy

Leuprorelin DRUG

Hormonal therapy

Also known as: Eligard

Radiotherapy combined with hormonal therapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
• 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.
• In case of chronic use of finasteride the PSA value should be \< 5 ng/ml.
• WHO performance state 0-2.
• Signed informed consent prior to registration/randomization.

You may not qualify if:

• 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 (\> level 1 pain medication) .
• Invasive active cancers other than superficial non-melanoma skin cancers.
• Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Dutch Cancer Society: collaborator

Study Sites (13)

Radiotherapiegroep

Arnhem, Gelderland, Netherlands

Location

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Location

Maastro Clinic

Maastricht, Limburg, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Location

Amsterdam UMC (Location VUmc)

Amsterdam, North Holland, Netherlands

Location

Radiotherapiegroep

Deventer, Overijssel, Netherlands

Location

Isala

Zwolle, Overijssel, Netherlands

Location

Radiotherapy Institute Friesland

Leeuwarden, Provincie Friesland, Netherlands

Location

Leinden University Medical Center

Leiden, South Holland, Netherlands

Location

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Location

Haga Hospital

The Hague, South Holland, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Verbeeten Institute

Tilburg, Netherlands

Location

Related Publications (1)

• Janssen J, Staal FHE, Brouwer CL, Langendijk JA, de Jong IJ, van Moorselaar RJA, Schuit E, Verzijlbergen JF, Smeenk RJ, Aluwini S. Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial. BMC Cancer. 2022 May 2;22(1):482. doi: 10.1186/s12885-022-09523-2.

  PMID: 35501744 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Radiosurgery; Leuprolide; luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• S. Al-Uwini, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: March 19, 2020
• Primary Completion (Estimated): October 21, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

NL (13)