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Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy. (PROPER2)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Prostate-Specific Antigen PSA, PSA, Radiation, Lymph node radiation, Prostate cancer recurrence, Randomized trial, Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jönköping County Hospital, RyhovRecruiting
  • Kalmar County HospitalRecruiting
  • Lund University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Continued salvage radiotherapy + lymph node irradiation (non responders)

Continued salvage radiotherapy (non responders)

Continued salvage radiotherapy (responders)

Arm Description

Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.

Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.

Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Systemic treatment-free survival.
Arms A and B will be compared regarding systemic treatment-free survival.
Distant metastasis-free survival.
Arms A and B will be compared regarding distant metastasis-free survival. survival.
Prostate cancer specific survival.
Arms A and B will be compared regarding prostate cancer specific survival survival.
Overall survival.
Arms A and B will be compared regarding overall survival.
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.
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.
Patients self-esteem of quality of life.
Arms A and B will be compared regarding quality of life.
Patients self-esteem of quality of life.
Arms A and B will be compared regarding quality of life.

Full Information

First Posted
April 12, 2021
Last Updated
April 27, 2021
Sponsor
Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04858880
Brief Title
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Acronym
PROPER2
Official Title
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
April 2030 (Anticipated)
Study Completion Date
April 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Prostate-Specific Antigen PSA, PSA, Radiation, Lymph node radiation, Prostate cancer recurrence, Randomized trial, Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
374 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continued salvage radiotherapy + lymph node irradiation (non responders)
Arm Type
Experimental
Arm Description
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
Arm Title
Continued salvage radiotherapy (non responders)
Arm Type
Active Comparator
Arm Description
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
Arm Title
Continued salvage radiotherapy (responders)
Arm Type
No Intervention
Arm Description
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice.
Intervention Type
Radiation
Intervention Name(s)
Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Failure-free survival (FFS).
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Systemic treatment-free survival.
Description
Arms A and B will be compared regarding systemic treatment-free survival.
Time Frame
Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Title
Distant metastasis-free survival.
Description
Arms A and B will be compared regarding distant metastasis-free survival. survival.
Time Frame
Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Title
Prostate cancer specific survival.
Description
Arms A and B will be compared regarding prostate cancer specific survival survival.
Time Frame
Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Title
Overall survival.
Description
Arms A and B will be compared regarding overall survival.
Time Frame
Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Title
Numbers of patients with acute toxicity (≤ 3 months after end of salvage radiotherapy).
Description
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.
Time Frame
Up to 3 months after end of salvage radiotherapy.
Title
Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy).
Description
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.
Time Frame
After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy.
Title
Patients self-esteem of quality of life.
Description
Arms A and B will be compared regarding quality of life.
Time Frame
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.
Title
Patients self-esteem of quality of life.
Description
Arms A and B will be compared regarding quality of life.
Time Frame
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.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only patients with prostate cancer are eligible.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adalsteinn Gunnlaugsson, MD, PhD
Phone
+46 46 17 75 20
Email
adalsteinn.gunnlaugsson@skane.se
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Sundberg, RN
Phone
+46 4617 70 34
Email
jan.sundberg@skane.se
Facility Information:
Facility Name
Jönköping County Hospital, Ryhov
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Björnlinger, MD
Phone
+46 10 241 00 00
Email
kirsten.bjornlinger@rjl.se
First Name & Middle Initial & Last Name & Degree
Kirsten Björnlinger, MD
Facility Name
Kalmar County Hospital
City
Kalmar
ZIP/Postal Code
391 26
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nandor Vass, MD
Phone
+46 480 84 000
Email
nandor.vass@regionkalmar.se
First Name & Middle Initial & Last Name & Degree
Nandor Vass, MD
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adalsteinn Gunnlaugsson, MD, PhD
Phone
+46 46 17 75 20
Email
adalsteinn.gunnlaugsson@skane.se
First Name & Middle Initial & Last Name & Degree
Jan Sundberg, RN
Phone
+46 46 17 70 34
Email
jan.sundberg@skane.se
First Name & Middle Initial & Last Name & Degree
Adalsteinn Gunnlaugsson, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

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