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

Lund University Hospital

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.

Study type: Interventional

Funder types: Other

Identifiers

NCT04858880

PRO-02

Details and patient eligibility

About

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.

Enrollment: 374 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 3 patient groups

Continued salvage radiotherapy + lymph node irradiation (non responders)

Experimental group

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.

Treatment:

Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.

Continued salvage radiotherapy (non responders)

Active Comparator group

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.

Treatment:

Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.

Continued salvage radiotherapy (responders)

No Intervention group

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.