Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

Prostate Cancer Clinical Trial

— PROPER2  

Official title:

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858880
• Other study ID #: PRO-02
• Status: Recruiting
• Phase: Phase 3
• Start date: April 9, 2021
• Est. completion date: April 2030

Study information

• Verified date: February 2024
• Source: Lund University Hospital
• Contact: Adalsteinn Gunnlaugsson, MD, PhD
• Phone: +46 46 17 75 20
• Email: adalsteinn.gunnlaugsson[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized phase III trial to study the effect of adding lymph node irradiation in patients with poor prostate-specific antigen (PSA) response during salvage radiotherapy for biochemical recurrence (0.15 ≤ PSA <0.70 ng/ml) after prostatectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 374
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Life expectancy > 10 years

• Age =18 years.

• World Health Organization (WHO) performance status 0-1.

• Estimated life expectancy >10 years.

• Histological evidence of prostate cancer in the prostatectomy specimen

• Primary tumor, regional nodes, metastasis (TNM): any primary tumor (pT), pathologically node-negative (pN0), M0.

• Biochemical Recurrence (BCR) after prostatectomy, with 0.15 = PSA <0.70 ng/ml.

• Patients must be able to comply with the protocol.

• Signed informed consent.

• Adequate laboratory findings (Haemoglobin (Hb) >90g/L, absolute neutrophil count >1.0x109/L, platelets >75x109/l, bilirubin <1.5x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <1.5 ULN).

Exclusion Criteria:

• Metastases (regional lymph nodes or distant)* diagnosed with imaging.

• Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone).

• Prior radiotherapy to the pelvis.

• Prior malignancy other than prostate cancer and basalioma in the past five years.

• Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (=6 months), unstable angina, New York Heart Association (NYHA) class III-IV congestive heart failure.

• Severe pulmonary disease.

• Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Radiation:
• Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
Radiation to the prostate bed with or without addition of radiation of lymph node irradiation (non responders). Patients with PSA response continues radiotherapy as initially planned, and are not followed according to the study protocol, only according to clinical practice.

Locations

Country	Name	City	State
Sweden	Jönköping County Hospital, Ryhov	Jönköping
Sweden	Kalmar County Hospital	Kalmar
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival (FFS).	Failure-free survival after salvage radiotherapy (SRT), with failure defined as either biochemical, defined as verified PSA level of = 0.2 ng/ml above the post-radiotherapy PSA nadir value or clinical Recurrence, imaging or biopsy confirmed.	FFS after SRT, with failure defined as either biochemical or clinical recurrence (imaging or biopsy confirmed). FFS is calculated from the randomization date (arms A and B) until end of follow up (month 60 after
Secondary	Systemic treatment-free survival.	Arms A and B will be compared regarding systemic treatment-free survival.	Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Secondary	Distant metastasis-free survival.	Arms A and B will be compared regarding distant metastasis-free survival. survival.	Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Secondary	Prostate cancer specific survival.	Arms A and B will be compared regarding prostate cancer specific survival survival.	Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Secondary	Overall survival.	Arms A and B will be compared regarding overall survival.	Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Secondary	Numbers of patients with acute toxicity (= 3 months after end of salvage radiotherapy).	Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity.	Up to 3 months after end of salvage radiotherapy.
Secondary	Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy).	Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity.	After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy.
Secondary	Patients self-esteem of quality of life.	Arms A and B will be compared regarding quality of life.	Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ-C30. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm B), month 12, 24, and 60.
Secondary	Patients self-esteem of quality of life.	Arms A and B will be compared regarding quality of life.	Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ - PR25. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm, month 12, 24, and 60.