Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220435
• Other study ID #: HYPO-RT-PC boost
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: September 1, 2031

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Adalsteinn Gunnlaugsson, MD, PhD
• Phone: +46 4617 6268
• Email: Adalsteinn.Gunnlaugsson[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.

Description:

HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study. Specific aims of the study are: - To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome). - To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer. - To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: September 1, 2031
• Est. primary completion date: September 1, 2031
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Life expectancy >5 years
• Age =18 years
• World Health Organization (WHO) performance status 0-2
• Histological evidence of prostate cancer
• Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 µg/L or and/or Gleason score 9-10 and/or PSA =40 µg/L
• At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI)
• Patients must be able to comply with the protocol
• Signed informed consent
• Adequate laboratory findings: haemoglobin (Hb) >90 g/L, absolute neutrophil count >1.0x10^9/l, platelets >75x10^9/l, bilirubin <2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <2.0x ULN)

Exclusion Criteria:

• Regional or distant metastasis
• Any contraindications for MRI
• PSA >150 ng/ml
• Previous pelvic radiotherapy
• Prior prostate surgery including transurethral resection of the prostate (TURP)
• Endocrine treatment (past or present)
• Other malignancies than prostate cancer and basalioma in the past five years
• Serious disease state that makes study inclusion and treatment unsuitable
• Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) =20)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Ultra-hypofractionated radiotherapy regimen.
Prostate tumor(s): 49 Gray (Gy)/7 fractions Prostate gland: 42.7 Gy/7 fractions Elective lymph nodes: 29.4 Gy/7 fractions Seminal vesicles: 31.15 Gy/7 fractions

Locations

Country	Name	City	State
Sweden	Region Skåne, Skåne University Hospital	Lund
Sweden	Region Västerbotten, Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 3+ Genitourinary Adverse Events	Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	start of treatment - 5 years
Secondary	Grade 2+ Genitourinary Adverse Events	Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0.	start of treatment - 5 years
Secondary	Failure-free survival		consent date - 5 years
Secondary	Local failure-free survival		enrollment date - 5 years
Secondary	Biochemical failure-free survival		enrollment date - 5 years
Secondary	Cancer-specific survival		enrollment date - 5 years
Secondary	Overall survival failure-free survival, cancer-specific survival, and overall survival		enrollment date - 5 years
Secondary	Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival		enrollment date - 5 years
Secondary	Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival		enrollment date - 5 years
Secondary	Adverse Events according to CTCAE v5.0		start of treatment - 5 years
Secondary	Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C-30)	All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems	inclusion date - 5 years
Secondary	Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR-25 (EORTC QLQ-PR25)	It includes subscales assessing urinary symptoms, bowel symptom), treatment-related symptom) and sexual functioning with score from 0 to 4 per item. A high scale score represents a higher response level.	inclusion date - 5 years