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Comparison of Intermittent Androgen Deprivation Therapy With or Without Irradiation Recovery in Prostate Cancer Patients (OLIGOPELVIS2)

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ClinicalTrials.gov Identifier: NCT03630666
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Direction Générale de l'Offre de Soins
Astellas Pharma Inc
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief Summary:

Metastatic prostate cancer has traditionally been regarded as an incurable dissemination of disease, and treatment is focused on delaying progression rather than eliminating all tumor burden. Local therapies, and specifically radiotherapy, have been directed at quality of life endpoints and not at improving survival. However, advances in imaging and systemic therapy have identified a population of 'oligometastatic' patients who have a lower burden of metastatic disease (usually ≤5 lesions), who may present an exception. This condition is hypothesized to occupy the hinterland between incurable metastatic disease and locoregional disease, where micrometastatic disease is assumed to exist and yet remain eradicable. Oligometastases can be detected using standard imaging but the sensitivity of these exams is very low for patients with a PSA below 10 ng/ml. In France, FCH PET imaging is now routinely available in a large majority of cancer centres. More recently, PSMA PET imaging has been developed.

Since most oligometastases are now discovered at a time when conventional imaging is unable to detect metastases, we must rely on the literature regarding purely biochemically-relapsing prostate cancer patients. Three strategies have been explored: (i) observation until symptoms develop, (ii) early intermittent Androgen Deprivation Therapy (IADT) and (iii) continuous Androgen Deprivation Therapy (ADT). Recent data suggest that, of the three strategies, early intermittent ADT was superior in term of overall survival to observation in controlling metastatic prostate cancer, and this effect was similar in the biochemically-relapsing prostate cancer patient population.

This phase III study will explore the role of salvage pelvic IG-IMRT combined with intermittent ADT (IADT) in pelvic oligometastatic patients in prolonging the first failure-free interval between the first and the second intermittent ADT courses.


Condition or disease Intervention/treatment Phase
Prostate Cancer Oligometastasis Drug: IADT Combination Product: IADT + radiotherapy Not Applicable

Detailed Description:

Screening procedures will be performed up to three months before starting IADT. After obtaining informed consent, patients will be randomly allocated to one of two groups:

Experimental group: IADT + IG-IMRT Control group: IADT

In both study arms, the first injection of IADT will be administered in hospital on the day of randomization. The overall duration of IADT will be six months.

In the experimental group, patients will receive radiotherapy three months after the first injection of IADT.

The overall duration of radiotherapy will be three months.

The overall duration of IADT will be six months. It will be administered three months, +/- 15 days prior to the first day of radiotherapy. At the completion of the six-month treatment period, a non-treatment interval will start if :

there is no evidence of clinical disease progression and the PSA level is ≤ 4.00 ng/ml If the PSA subsequently rises above 0.20 ng/ml and is confirmed by a second measurement at least three weeks later, PET/CT imaging will be repeated every 6 months until a clinical failure is detected or until the PSA rises above 4.00 ng/ml.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: phase 3 study, randomised, open
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Comparing Intermittent Androgen Depriving Therapy With Or Without Salvage High-Dose Intensity Modulation Radiotherapy (IG-IMRT)To Oligometastatic Pelvic Lymph Nodes In Biochemically-relapsing Prostate Cancer Patients.
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: IADT
one injection of IADT. The overall duration of IADT will be six months.
Drug: IADT
Patient will receive one injection of IADT at randomization
Other Name: LH-RH (Luteinizing Hormone Releasing Hormone) agonist

Experimental: IADT+ radiotherapy
One injection of IADT. The overall duration of IADT will be six months. Irradiation three months after injection of IADT. The overall duration of radiotherapy will be three months.
Combination Product: IADT + radiotherapy
Patient will receive one injection of IADT at randomization then will receive irradiation 3 months after injection of IADT
Other Names:
  • IG-IMRT
  • LH-RH (Luteinizing Hormone Releasing Hormone) agonist




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 90 months ]
    PSA or CT scan


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 90 months ]
    death

  2. time to castration-resistance [ Time Frame: 90 months ]
    serum testosterone mesure

  3. toxicity to IADT and radiation [ Time Frame: 90 months ]
    evaluation with NCI-CTC AE v4.03

  4. quality of life during treatment [ Time Frame: 90 months ]
    questionnaire PR25

  5. quality of life during treatment [ Time Frame: 90 months ]
    questionnaire EQ-5D-3L

  6. quality of life during treatment [ Time Frame: 90 months ]
    questionnaire EORTC QLQ-C30 v3.0

  7. site of tumor progression [ Time Frame: 90 months ]
    FCH or PSMA PET at biochemical relapse



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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-proven prostate adenocarcinoma
  • Age ≥ 18 years
  • Performance Status 0-1
  • Prior radical prostate treatment (surgery and/or radiotherapy)
  • ≤ 5 metastatic pelvic lymph nodes detected by FCH-PET or PSMA-PET
  • Upper limit of metastatic lymph nodes: aortic bifurcation
  • If ADT has been previously administered to the patient, at least 12 months must have elapsed between the predicted duration of the last injection and inclusion of the patient in the study. For this category of patients, serum testosterone must be higher than 6 nmol/L (50 ng/L) prior to inclusion
  • Biochemical relapse (according to the European Association of Urology guidelines) is defined by :

Following radical prostatectomy (RP), biochemical recurrence (BCR) is defined by two consecutive rising PSA values > 0.20 ng/ml After primary radiation therapy (RT), the Radiation Therapy Oncology Group (RTOG) and American Society for Radiation Oncology Phoenix Consensus Conference definition of PSA failure is any PSA increase > 2.00 ng/ml higher than the PSA nadir value, regardless of the serum concentration of the nadir.

  • Having given written informed consent prior to any procedure related to the study.
  • Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations.
  • Patient has valid health insurance
  • Subjects who have partners of childbearing potential must be willing to use a method of effective birth control during treatment and for 12 months following completion of treatment with ADT or IG-IMRT.

Exclusion Criteria:

  • Bone or visceral metastases
  • Para-aortic lymph node metastases (above the aortic bifurcation)
  • Presence of more than five metastatic lymph nodes
  • Evidence of local intra-prostatic relapse
  • Evidence of prostate bed relapse in a previously irradiated region. Prostate bed relapses which have not been previously irradiated will not be excluded
  • Evidence of metastasis at initial diagnosis
  • Evidence of distant metastases beyond the pelvic lymph nodes
  • Previous irradiation of pelvic lymph nodes
  • Castration-resistant prostate cancer (CRPC) as defined by : a castrate serum testosterone < 6 nmol/L (50 ng/L)
  • Contraindications to pelvic irradiation (e.g. chronic inflammatory bowel disease)
  • Contraindications to ADT (known hypersensitivity to any of the study drugs or excipients)
  • Severe uncontrolled hypertension defined as systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
  • Other malignancy treated within the last 5 years (except non-melanoma skin cancer)
  • Patients with a biochemical relapse while on active treatment with LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, or oestrogen
  • Treatment during the past month with products known to influence PSA levels (such as finasteride)
  • In case of previous prostate/prostate bed radiotherapy, PET-positive lymph nodes have to be located outside the previous irradiation field with a maximum of 20 Gy to the PET-positive lymph nodes region
  • Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days
  • Disorder precluding understanding of trial information or informed consent

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): NCT03630666


Contacts
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Contact: STEPHANE SUPIOT, MD 02 40 67 99 00 ext +33 stephane.supiot@ico.unicancer.fr
Contact: MARINE TIGREAT 0241352821 ext +33 marine.tigreat@ico.unicancer.fr

Locations
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France
Institut Sainte Catherine Recruiting
Avignon, France, 84918
Contact: LYSIAN CARTIER, MD       l.cartier@isc84.org   
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: PAUL SARGOS, MD       p.sargos@bordeaux.unicancer.fr   
CHRU de Brest Active, not recruiting
Brest, France, 29200
Clinique Pasteur Recruiting
Brest, France, 29200
Contact: ALI HASBINI, MD       alihasbini@oncologie-brest.fr   
Institut de Cancérologie de Bourgogne Recruiting
Chalon-sur-Saône, France, 71100
Contact: BENJAMIN SCHIPMAN, MD       benschipman@yahou.fr   
Centre Jean Perrin Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: GENEVIEVE LOOS, MD       Genevieve.LOOS@clermont.unicancer.fr   
Centre Georges François Leclerc Recruiting
Dijon, France, 21079
Contact: GILLES CREHANGE, MD       GCrehange@cgfl.fr   
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: DAVID PASQUIER, MD       d-pasquier@o-lambret.fr   
Centre Léon Bérard Not yet recruiting
Lyon, France, 69373
Contact: PASCAL POMMIER, MD       pascal.pommier@lyon.unicancer.fr   
Institut de Cancérologie de Montpellier Not yet recruiting
Montpellier, France, 34298
Contact: DAVID AZRIA, MD       david.azria@icm.unicancer.fr   
Centre Azureen de Cancerologie Recruiting
Mougins, France, 06250
Contact: PHILIPPE RONCHIN, MD       ronchinp@yahoo.fr   
Institut de Cancérologie Recruiting
Nantes, France, 44000
Contact: STEPHANE SUPIOT, MD    02 40 67 99 13 ext +33    Stephane.Supiot@ico.unicancer.fr   
Contact: MARINE TIGREAT    02 40 67 98 78 ext +33    marine.tigreat@ico.unicancer.fr   
Hopital Privé du Confluent Not yet recruiting
Nantes, France, 44277
Contact: XAVIER BUTHAUD, MD       xavier.buthaud@groupeconfluent.fr   
Clinique Mutualiste de l'Estuaire Not yet recruiting
Saint-Nazaire, France, 44600
Contact: PHILIPPE BERGEROT, MD       philippe.bergerot@mla.fr   
ICL Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42271
Contact: NICOLAS MAGNE, MD       nicolas.magne@icloire.fr   
Centre Saint Yves Not yet recruiting
Vannes, France, 56000
Contact: ERIK MONPETIT, MD       mylittle@centre-st-yves.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Direction Générale de l'Offre de Soins
Astellas Pharma Inc
Investigators
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Principal Investigator: STEPHANE SUPIOT, MD Institut de Cancérologie de l'Ouest
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03630666    
Other Study ID Numbers: ICO-N-2017-13
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Oligometastatic pelvic lymph nod, IADT, radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Hormones
Prolactin Release-Inhibiting Factors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs