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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302454
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Shafak Al-Uwini, University Medical Center 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiotherapy Drug: Leuprorelin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Radiotherapy without hormonal therapy
Metastase-directed radiotherapy without the addition of hormonal therapy
Radiation: Radiotherapy
Radiotherapy
Other Names:
  • MDRT
  • Metastase-directed radiotherapy
  • SBRT
  • Stereotactic body radiotherapy

Experimental: Radiotherapy combined with hormonal therapy
Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)
Radiation: Radiotherapy
Radiotherapy
Other Names:
  • MDRT
  • Metastase-directed radiotherapy
  • SBRT
  • Stereotactic body radiotherapy

Drug: Leuprorelin
Hormonal therapy
Other Name: Eligard




Primary Outcome Measures :
  1. Metastases progression-free survival (MPFS) [ Time Frame: 2.5 years after treatment ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302454


Contacts
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Contact: Jorinde Janssen, MD 0031631623127 j.janssen02@umcg.nl
Contact: P. Veldhuijzen van Zanten 0031503614659 adopt@rt.umcg.nl

Locations
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Netherlands
Radiotherapy Institute Friesland Not yet recruiting
Leeuwarden, Friesland, Netherlands
Contact: M. de Jong, MD         
Radiotherapiegroep Not yet recruiting
Arnhem, Gelderland, Netherlands
Contact: M. A. D. Haverkort, MD         
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands
Contact: R.J. Smeenk, MD, PhD         
Maastro Clinic Recruiting
Maastricht, Limburg, Netherlands
Contact: B. Vanneste, MD, PhD         
Catharina Hospital Not yet recruiting
Eindhoven, Noord-Brabant, Netherlands
Contact: T.C.G. Budiharto, MD, PhD         
Amsterdam UMC (Location VUmc) Not yet recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: J. van Moorselaar, Professor         
Radiotherapiegroep Not yet recruiting
Deventer, Overijssel, Netherlands
Contact: M.A.D. Haverkort, MD         
Isala Not yet recruiting
Zwolle, Overijssel, Netherlands
Contact: O. Reerink, MD, PhD         
Haga Hospital Not yet recruiting
Den Haag, Zuid-Holland, Netherlands
Contact: B. Hollmann, MD         
Leinden University Medical Center Not yet recruiting
Leiden, Zuid-Holland, Netherlands
Contact: S. Rademakers, MD, PhD         
Erasmus Medical Center Not yet recruiting
Rotterdam, Zuid-Holland, Netherlands
Contact: K. de Vries, MD         
UMCG Recruiting
Groningen, Netherlands
Contact: J. Janssen, MD    0031631623127      
Verbeeten Institute Not yet recruiting
Tilburg, Netherlands
Contact: M.A.E. vd Sande, MD         
Sponsors and Collaborators
University Medical Center Groningen
Dutch Cancer Society
Investigators
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Principal Investigator: S. Al-Uwini, PhD UMCG
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Responsible Party: Shafak Al-Uwini, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04302454    
Other Study ID Numbers: RT2019-13
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents