E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer |
Prostaatkanker |
|
E.1.1.1 | Medical condition in easily understood language |
Prostate cancer |
Prostaatkanker |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071119 |
E.1.2 | Term | Hormone-dependent prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To analyse the safety of oestradiol in the setting of endocrine treatment for locally extended prostate cancer adjuvant to radiotherapy. |
Analyseren van de veiligheid van oestradiol als adjuvante endocriene behandeling bij radiotherapie bij lokaal gevorderde prostaatkanker. |
|
E.2.2 | Secondary objectives of the trial |
1) Analyse compliance to the study intervention (measured by oestradiol serum levels)
2) Analyse the incidence of endocrine therapy related side effects
3) Analyse changes of metabolic serum parameters
4) Analyse time to reach testosterone castration levels
5) Analyse quality of Life (EORTC QC 30, PR25 potency, overall) |
1) Bepalen van het juiste gebruik van de studiemedicatie (gemeten door bepaling van het serum oestradiol).
2) Bepalen van de incidentie van endocrien gerelateerde bijwerkingen.
3) Bepalen van veranderingen in de metabole serum parameters.
4) Bepalen van de tijd tot het bereiken van testosteron castratieniveau.
5) Bepalen van de kwaliteit van leven (EORTC QC 30, PR25, algeheel). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Men ≥ 18 years.
2) Locally advanced prostate cancer.
3) Selected for at least two years of adjuvant endocrine therapy and EBRT.
4) Signed informed consent.
5) Testosterone serum level > 6 nmol/l. |
1) Mannen ≥ 18 jaar.
2) Lokaal gevorderde prostaatkanker.
3) Geslecteerd om minstens twee jaar te worden behandeled met adjuvante endocriene therapie en uitwendige bestraling.
4) Getekend toestemmingsformulier.
5) Serum testosteron serum > 6 nmol/l. |
|
E.4 | Principal exclusion criteria |
1) Current endocrine treatment or previous therapy within 6 months (5-alpha reductase inhibitors are permitted).
2) Previous radiological confirmed deep venous thrombosis or pulmonary embolus.
3) Cerebrovascular event (TIA or CVA) within 6 months.
4) Coronary heart disease within 6 months.
5) Instable angina pectoris within 6 months.
6) Congenital thrombofilic diseases.
7) Thrombolic disease within 6 months.
8) Heart failure as defined by NYHA class >2.
9) Hypertension (not corrected by medication) >160/100 mmHg. If either systolic or diastolic value is higher than these values the patient is not eligible.
10) Suboptimal regulated diabetes mellitus or de novo diabetes mellitus as defined by HbA1c of over 6,5% (48 mmol/mol).
11) Rheumatoid arthritis.
12) Impaired renal function as defined by a GFR < 30 ml/ min/1,73 m2
13) Acute liver failure or reduced liver function showing as increased serum parameters (SGOT, SGPT, bilirubine > 2.5 times normal).
14) Porfyria. |
1) Patiënt wordt momenteel of is in de afgelopen zes maanden behandeld met endocriene therapie(5-alpha reductase remmers zijn toegestaan).
2) Radiologisch bevestigde diep veneuze trombose of pulmoniare embolie in de voorgeschiedenis.
3) Cerebrovasculair aandoening (TIA or CVA) in de afgelopen 6 maanden.
4) Coronaire hartziekte in de afgelopen 6 maanden.
5) Instabiele angina pectoris in de afgelopen 6 maanden.
6) Congenitale thrombofiele aandoeningen.
7) Thrombolitische aandoening in de afgelopen 6 maanden.
8) Hartfalen, gedefinieerd als NYHA klasse >2.
9) Hypertensie (niet gecorrigeerd door medicatie) >160/100 mmHg. Als ofwel de systolische ofwel de diastolische waarde hoger is dan deze warden, komt de patiënt nietin aanmerking voor deelname.
10) Suboptimaal gereguleerde diabetes mellitus of de novo diabetes mellitus, gedefinieerd als HbA1c >r 6,5% (48 mmol/mol).
11) Rheumatoïde artritis.
12) Verstoorde nierfunctie, gedefinieerd als GFR < 30 ml/ min/1,73 m2
13) Acuut leverfalen of afgenomen leverfunctie die zich uit in verhoogde serum parameters (SGOT, SGPT, bilirubine > 2.5 keer de normaalwaarde).
14) Porfyria. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of cardiovascular events (number of cardiovascular events per 100 person years). |
Incidentie van cardiovasculaire incidenten (aantal cardiovasculaire incidenten per 100 persoonsjaren). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Compliance to the study intervention (measured by oestradiol serum levels at every visit).
2) Incidence of endocrine related side effects.
3) Changes of metabolic serum parameters (liver function (SGOT, SGPT, bilirubin), endocrine (oestradiol, testosterone, PSA), lipid profile (HbA1c, cholesterol, HDL).
4) Time to reach testosterone castration levels (during run-in period, T ≤ 1.7 nmol/L).
5) Quality of Life (EORTC QC 30, PR25 potency, overall). |
1) Nakomen van het gebruik van de studiemedicatie (gemeten door bepaling van het serum oestradiol tijdens iedere visite)
2) Incidentie van endocrien gerelateerde bijwerkingen
3) Veranderingen in de metabole serum parameters (lever functie (SGOT, SGPT, bilirubine), endocrien (oestradiol, testosteron, PSA), lipiden profiel (HbA1c, cholesterol, HDL).
4) Tijd tot het bereiken van testosteron castratieniveau (tijdens de run-in periode, testosteron ≤ 1.7 nmol/L).
5) Kwaliteit van leven (EORTC QC 30, PR25, algeheel) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit (follow-up phone call) of the last participant. |
Laatste visite (telefonische follow-up) van de laatste deelnemer. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |