NCT07717268 Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients.
| NCT ID | NCT07717268 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic |
| Condition | Prostatic Neoplasms, Castration-Resistant |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2024-05-16 |
| Primary Completion | 2030-05-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 51 participants in total. It began in 2024-05-16 with a primary completion date of 2030-05-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objectives of the study are to analyze the results obtained in survival, safety and quality of life after the combination of SBRT plus second-generation antiandrogen in patients diagnosed with metastatic castration-resistant prostate cancer in oligometastasis (≤5). Hence, the investigators evaluate the results of the combination of two widely used treatments in prostate cancer: SBRT plus the 'standard of care' for patients with mCRPC, second-generation antiandrogens (abiraterone and enzalutamide). Primary objective: Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT. Secondary objectives: * Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT. * Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients. * Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale. This is a phase II, multicenter, prospective, single group study in patients with castrate-resistant prostate cancer (CRPC). Patients will be recruited at the participant sites, after study approval and hospital authorization. 51 patients will be included in the study. Eligible patients will require: * Choline PET/CT or 68Ga-PSMA PET/CT, dated no more than 8 weeks prior to inclusion. * Clinical history, physical examination and functional evaluation scale (ECOG). * Geriatric assessment scale for patients \> 75 years (modified G8 scale) * Toxicity scale assessment (CTCAEv5.0) * Baseline quality of life questionnaire (EORTC QLQ-C30) (47) * Blood tests with complete blood count, coagulation, liver function, renal function, ions, alkaline phosphatase, PSA and total and free testosterone, dated no more than 4 weeks prior inclusion. * Inclusion/exclusion criteria assessment * Second generation antiandrogen prescription, chosen by the responsible physician according to clinical practice, in each case. Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus. Recruitment time is estimated at 36 months and a total follow-up time of 36 months. The total duration of the trial is therefore expected to be 6 years, to allow complete follow-up of the last patients included.
Eligibility Criteria
Inclusion Criteria: * Patients with histologically prostate adenocarcinoma, confirmed with a biopsy. * Testosterone in biochemical castration ranges (testosterone \<50 ng/ml or 1.7 nmol/L) and documented progression: biochemical according to Phoenix criteria or distant by radiological confirmation (PSMA PET/CT or Choline PET/CT) * Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone \<50 ng/ml or 1.7 nmol/L). * Radiological confirmation (with choline-PET/CT or 68Ga-PSMA-PET/CT) of ≤5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (\< 3 cm major diameter in bone metastases, \< 5 cm in lymph node metastases). In the case of very close metastases, a limit of up to 5 treatment fields with SBRT is allowed, instead of 5 metastases. * Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study. or or who has started treatment no more than 14 days prior to signing, as first-line treatment after a diagnosis of oligoresistance. * Patients must provide written informed consent. * Life expectancy \> 3 months. Exclusion Criteria: * Patients with prostate carcinoma with histology other than adenocarcinoma. * No previous biopsy. * \> 5 metastasis, not approachables in 5 treatment fields * Patients with visceral metastasis and or metastasis non elegible to receive SBRT. * Patients with Testosterone above castration levels * Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.
Contact & Investigator
Marta Barrado Los Arcos, MD
PRINCIPAL INVESTIGATOR
Hospital of Navarra
Frequently Asked Questions
Who can join the NCT07717268 clinical trial?
This trial is open to male participants only, studying Prostatic Neoplasms, Castration-Resistant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07717268 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07717268 currently recruiting?
Yes, NCT07717268 is actively recruiting participants. Contact the research team at investigacion@seor.es for enrollment information.
Where is the NCT07717268 trial being conducted?
This trial is being conducted at Zaragoza, Spain, Barcelona, Spain, L'Hospitalet de Llobregat, Spain, Bilbao, Spain and 11 additional locations.
Who is sponsoring the NCT07717268 clinical trial?
NCT07717268 is sponsored by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic. The principal investigator is Marta Barrado Los Arcos, MD at Hospital of Navarra. The trial plans to enroll 51 participants.