NL-OMON47400
Recruiting
Phase 3
INTense Exercise foR surVivAL among men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC): A Multicentre, Randomised, Controlled, Phase III Study - INTERVAL - MCRPC
The Movember Foundation0 sites46 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- urologische aandoeningen
- Sponsor
- The Movember Foundation
- Enrollment
- 46
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Patients must be mCRPC. This is defined as adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (\<50 ng/dL) due to orchiectomy or LHRH agonist.
- •o Patients must have one or more of the following to be considered mCRPC
- •\* Metastatic Disease Progression: \>20% increase in the sum of diameters of measurable lesions from the time of maximal regression or appearance of one or more new lesions.
- •\* Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer.
- •\* PSA Progression: PSA \>\=2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 \< PSA2 \< PSA3\).
- •\* Castrate levels of testosterone must be maintained while on study. Be on androgen deprivation therapy (ADT) with a GnRH agonist/antagonist or prior bilateral orchiectomy. All patients will be required to be on ADT during the study period or have had a prior bilateral orchiectomy. Men with small cell neuroendocrine tumours or features of small cell disease are not eligible.
- •\* At enrolment, patients must fit into one of the following 5 categories:;1\. Treatment naïve for mCRPC (have not yet started approved therapies for CRPC ie: Abiraterone/Enzalutamide/ Apalutamide/Docetaxel; less than 4 weeks on approved therapies is still considered to be treatment naïve)
- •2\. Receiving Abi/Enza/Apa for mCRPC AND responding or stable (PSA values must be stable or declining after at least 4 weeks since starting Abi/Enza/Apa for mCRPC)
- •3\. Patients with PSA progression while on Abi/Enza/Apa are eligible as long as they are asymptomatic AND there is no intent on starting chemotherapy within 6 months
- •Or;4\. Patients treated with Docetaxel as first line therapy for mCRPC who are asymptomatic without ANY evidence of progression
Exclusion Criteria
- •\* Previous radiographic or clinical progression (PSA progression is permitted) while on treatment with abiraterone, enzalutamide, apalutamide, or a combination.
- •\* Previously identified small cell neuroendocrine tumours or pure small cell carcinoma of the prostate, based on a prior biopsy of the prostate.
- •\* Brain metastases (brain imaging is not required)
- •\* Previous and/or concurrent treatment with other anti\-cancer treatments is permitted. Patients are allowed to be treated with chemotherapy during the duration of the trial. Patients who have received chemotherapy as part of initial androgen deprivation therapy for metastatic castration sensitive disease are eligible.
- •\* Currently receiving experimental treatment with non\-approved drugs at the time of enrolment. Patients must undergo a 28\-day washout between last dose and screening CPET.
- •\* Poorly controlled hypertension. During screening \>\=2/3 of readings must be \< 160/90, regardless of whether on a regimen of anti\-hypertensive therapy or not.
- •o If patient is currently taking hypertensive medication(s)/therapy, please indicate medication and include in the Treatment and Concomitant Medications Log (SOM: Appendix 11\).
- •\* Current congestive heart failure (New York Heart Association Class II, III or IV)
- •\* Recent serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI).
- •\* Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient.
Outcomes
Primary Outcomes
Not specified
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